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" T I T A N I C 2020 - A C A L L TO A C T I O N "
by Rich Lysakowski and Zahava Leibowitz
1
Executive Summary
The potential electronic crisis predicted to hit the Western world upon entering the Year 2000 was
the subject of global concern for many months, if not years. The airwaves were filled with the
speculations of everyone from diskjockeys to systems analysts to politicians on whether public
utilities, banks, or nuclear weapons would fail. Y2K Plus, a company specialized in solving Year
2000 computer problems, estimated that the cost of prevention and repair of Y2K technical
problems will total approximately $750 billion dollars. With legal preparations and litigation the
total cost will likely be over 1 trillion dollars, l Intense preparations for years, replacing old
computers and rewriting millions of software programs spared the world from major problems.
While it is no wonder that Y2K inspired thoughts of a coming apocalypse, a much larger and very
real ci'isis is on the horizon now -- one we call "Titanic 2020." It has been brewing for a long time
and grows larger everyday. Titanic 2020 results from software business practices that make new
products quickly obsolete, cause major hassles for users, and put critical assets at risk. Comparing
Titanic 2020 to Y2K, Y2K was like the tip of an iceberg. Like the passengers on the Titanic on her
maiden voyage, many of our most valuable records stored by the ship of computers will perish.
Icebergs are dangerous becausethey do not reveal their size until we get very close to them.Unlike
the iceberg that sank the original Titanic, the iceberg looming in our future is man-made. Titanic
2020 is not just one iceberg or one definite deadline like Y2K -- it will be many icebergs scattered
across many future horizons. By then it is too late because the real danger is below the horizon.
Simply stated, Information Technology (IT) of the early 21 st Century-- and the organizations that
use IT -- are generally ill prepared to prevent damage or loss of valuable electronic records or data.
Every time we migrate electronic records or data stored in computer systems to the next generation
of technology, we potentially face perilous collisions. Some collisions will lose priceless personal
data and records. Until some important changes occur in Information Technology itself, large
losses will mount. Every organization that uses computers for storing critical data or legal records
will have Titanic collisions and full-blown disasters from irrecoverable data and violated records.
Countless personal and professional lives will be lost in failed rescue attempts. Costly lawsuits to
recover damages for lost properties will tie up courtrooms for years.
This report identifies the primary causes of the impending disasters we will all face as we rush into
our digital future. It provides an economic analysis of a recent, extremely costly software migration
that resulted from incompatible data formats. The example is at once practical, symbolic, and
symptomatic of the problems for technology users caused by the software industry at large choosing
a strategy of rapid planned obsolescence. The report also admonishes users to take back ownership
of access to their data because today, guaranteed long-term access to records requires a continual
subscription with an unknown cost-of-ownership price tag. Lastly, this is a Call to Action to reduce
the risks and costs of ownership of Information Technology to finally support permanent electronic
records by changing business strategies and buying behaviors. The Titanic 2020 problems are well
understood, and will persist by design, until this Call to Action is heeded.
i See Ted Smalley Bowen. "Y2K Legal Wrangling Escalates." InfoWorld, November 29, 1999, Cover Story.
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L
The Origin of Titanic 2020
The Titanic 2020 icebergs started to nucleate at the start of the Information Age, roughly in the mid1960s, when we started to rely on electronic computers for business records. The icebergs have
been growing rapidly in size and number since then. IT systems of the early 21st Century create
and store "fragile" electronic records and data, meaning their integrity is easily broken when they
are removed from the technology that was used to create them. Once broken, an electronic record's
integrity cannot easily be restored. At first, electronic records were mostly historical in nature, but
increasingly we create them for critical business and scientific matters too. For society to move all
the way into The Information Age, we need to replace paper and microfilm as the default permanent
storage media for data created electronically. We must still take some important transitional steps.
The Y2K problem was the result of using a shorthand, two-digit year code instead of a full fourdigit date code. However, for modem electronic records, this date code is only one item in a long
list of parameters that must be kept to ensure integrity and access in the future. Like the Y2K
problem, which is the result of a lack of concem over the past 30 years with a known parameter
problem, the problems leading to Titanic 2020 are also known, but little to no action is being taken
to correct them. We continue to produce digital records in formats with short life spans that are
increasingly difficult and sometimes impossible to access years later.
"Titanic 2020" is a moniker for the serious problem of widespread software design flaws in today's
IT systems. These design flaws will affect every organization that must keep today's electronic
records well into the 21st Century. Every organization is building its own fleet of Titanic ships in
the form of electronic records technology systems and data systems. Many of the records these
vessels carry will be shipwrecked on the dozens of icebergs growing in the future seas of IT. Each
migration event is a point in time when records must change carriers and preserve their full integrity
and accessibility. In front of each migration event on the horizon floats a potential man-made
iceberg with a size and shape unknown at this time.
The designs of today's IT systems simply do not permit facile or reliable migration of their contents,
at a predictable or reasonable cost. Unwittingly, by our own design, we keep creating the ships
without lifeboats to carry us safely into the future. Not only are we as a society failing to take note
of the problem looming over us, like the builders of the Titanic, we are continually taking steps to
seal our fate.
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Focus of This Report
This report focuses primarily on legal records; however, in most cases it applies equally well to less
formal or secure compilations of "data." Legal experts widely agree that electronic records and data
are admissible in court as evidence. They also agree that electronic data can have a legal weight
equivalent to formal, signed legal records -- as long as the data integrity has been preserved beyond
a shadow of a doubt since the time of its creation to the time of its surrender in legal proceedings.
This report focuses on matters of critical concern to individuals, businesses, and governments.
Individuals may think a report about electronic records does not apply to them, since they may use
personal digital devices to create data for their eyes only. However, this report applies to any
collection of any information with integrity that you may want to preserve and access years later.
At the individual level, personal digital devices make our lives easier on a daily basis. We
increasingly rely on them in our daily lives. However, digital devices do not yet provide reliable
and easy ways to move our digital results across generations of technology. Digital records
sometimes change irreversibly as we move them across different devices and software packages
over time -- sometimes altering critical characteristics of authenticity, reliability, or accuracy that
allow them to be used as historical records later. We increasingly entrust priceless sentimental
works and events to digital-only devices. If a record's content is not entirely lost in migration,
sometimes it can be corrupted or damaged irreversibly, a fact which may only be discovered after
great personal loss of time trying to recover it. Such time and effort spent to reliably migrate digital
data through software versions over time needlessly encumbers and wastes our personal lives.
At the levels of business and government, records are the lifeblood of accountability for past
actions, and data are the basis for current actions. Data can be useful for very long periods of time
even though it changes from one data processing software to the next, and from one computer
System to the next. At some point processing stops, conclusions are reached, and a permanent
record is created. In the rush to become ever more efficient and effective, manage knowledge and
leverage intellectual capital, we have overlooked the vessels to carry electronic records of action far
into the future for both legal and historical reasons. In any endeavor, seeds for tomorrow's success
come from today's intellectual property and other recordings of knowledge. We are killing those
seeds by using vessels that can easily sink and destroy the integrity of the seeds. At the same time,
we are creating unknown legal and economic problems and losses for ourselves that will be nearly
impossible to estimate until they are upon us.
:--..
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The US National Archives" Experienced Sea Captains in Need of Better Ships
As the keeper of the government's records, the United States National Archives and Records
Administration (NARA) was among the first groups to experience, on a relatively small scale, the
danger that lies in front of us all. Its buildings in and around Washington, D.C. are packed with as
many records as they can physically hold, including many original audio and video recordings of
historic moments in time, all on various forms of outdated media. In order to access these media,
the original audio players and video projectors must be reconstructed and then each recording must
be played -- sometimes in its entirety -- in order to catalogue its contents and separate out accessible
from inaccessible information and key historical information from the unimportant. Due to a lack
of funding and resources, many of these records will molder, crumble, or rust before they can be
reviewed and catalogued by archivists. It is part of NARA's responsibility to decide which records
submitted to them they will have the resources to preserve in an accessible form and which are
beyond their resources (and may be lost forever.) 2
Digital media such as digital audio, digital video, and other more complex digital data types
(scientific, engineering, and business data) are rapidly proliferating. Digital media is quickly
becoming the preferred recording method -- strongly favored over traditional paper and analog
methods. Digital formats permit innovative computer processing, searching, mining, and reuse of
all types of knowledge. However, accompanying this ease of use is "The Digital Time Bomb" - an
indefinite period of time after which data is inaccessible because no one paid money or attention to
ensure its accessibility. Complex digital records are increasingly difficult to deal with because there
are few universal standards for long-term preservation and access. Each software supplier creates
its formats and changes them as needed for a variety of reasons. Many people hope that the World
Wide Web and technologies such as the eXtensible Markup Language (XML) will offer some
stability and solve universal access problems. However at the current frenetic pace of innovation
and market competition, chaos will remain the norm until enough end users and suppliers are
organized and work together effectively to produce stability in the marketplace. Currently, nearly
everyone using computers is forced into a defensive position of preserving records in the lowest
common formats -- in the worst cases -- by printing to paper.
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Modern Records: They Don't Build Them Like They Used To
The problem faced by the US National Archives is in many ways much simpler than Titanic 2020.
The records stored at NARA represent only the history of the US Federal Government. NARA's
repositories hold historical records of operations of all branches of government and public service
since the United States was formed. NARA's records are the primary instruments of accountability
of past public administrations. NARA typically does not receive records from a public
administration until after it leaves office. While the records hold tremendous value with respect to
our understanding of who the American People are and how they got to the present, loss of these
records is unlikely to dramatically affect the day to day lives of most citizens. Such is not the case
with most electronic records being created today in business or by individuals.
Most electronic records today are produced and relied upon in the normal course of everyday
business. Individuals become most aware of how much they are affected by the integrity of these
records when their bank statement or credit card bill has an error. Businesses are even more
2 See Stille, Alexander. "Overload." New Yorker. March 8, 1999, p38ff.
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dependent on the integrity of their records, since record integrity is critical to defending patent
rights, demonstrating compliance with government regulations, defending tax returns, etc. As the
world population grows rapidly, and society becomes increasingly litigious, the number of records
that individuals and businesses must create and depend upon is increasing exponentially.
6
The Growth of Electronic Records
Accurate models of the growth of electronic records are difficult to construct, but we know that
several factors are important. The most important ones are population growth and the accelerating
adoption of information technologies to achieve greater efficiencies of scale and sharing of
knowledge than paper-based systems can provide.
Models of growth for the Earth's population provide the most compelling drivers of growth.
Population experts predict that the global population will expand to around 11 billion by 2050 and
potentially to 24.8 billion by 2150. 3 It is obvious that for each person an increasing number of vital
records must be kept: certificates of birth and death; marriage and drivers licenses; mortgages,
stocks and other property transactions, plus many other types of routine transactions that we need or
want to record. With so many transactions of lasting legal value, it is easy to see that the number of
records will continue to grow exponentially. In fact, most institutions today-- whether corporate,
government, or even small businesses -- harbor not-so-secret fears that the volume of important
records is growing so fast that they will soon become, if they are not already, impossible to manage.
NARA provides a good example of the explosive growth of electronic records. Between 1972 and
1989, NARA archived 5000 electronic record files. Between 1989 and 1999, it archived 100,000
electronic records. In 2000, it expects to archive at least 1,000,000 records. In 2002, NARA
expects to archive at least 40,000,000 e-mail records from the Clinton Administration White House
alone. Simultaneously, it is preparing to archive approximately 90,000,000 personnel records from
other branches of government. 4 NARA does not archive state and local records, that is the duty of
state and local archives. Nor does NARA archive the millions of records of experimental and
medical research, tax records, or countless other types of confidential records that could be
important to future citizens. Generally each institution must archive their own records, unless they
are of particular historical importance to the public.
Jean-Pierre Wallot, the former National Archivist of Canada, stated in 1994 that "more records have
been generated during the past ten years than in all of prior human history. ''5 Because of the rapid
adoption of computers for business in the Information Age, the time required to double the number
of critical records is decreasing rapidly. At the current rate, the number of records will double in 5
years, and double again less than 3 years later. If the number of records continues to grow at the
same rate of growth as that of the human population, the numbers are staggering; simple math tells
us that within lO years, the number o f records produced on theplanet could be doubling every 60
minutes.
3 Population Division of the Department of Economic and Social Affairs of the United Nations Secretariat (1999).
Long-range World Population Projections: Based on the 1998 Revision. (ESA/P/WP.153).
4 Ken Thibodeau, Director of the Center for Electronic Records Archiving at NARA supplied these statistics.
5 See Wallot, Jean-Pierre, The National Archivist of Canada. "Archival Oneness in the Midst of Diversity" American
Archivist, Vol. 57, Number 2, Spring 1994, pg. 380.
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Luckily, several mitigating factors will constrain the problem somewhat. Good records
management practices dictate that business are only required to retain records for the number of
years mandated by law. Some types of records can be deleted soon after their creation. For
example, electronic commerce transaction records are short-lived, requiring retention for only two
to three years. The IRS requires that personal tax returns only be kept for 7 years.
The Titanic 2020 problem is compounded by the fact that longer retention periods are mandated by
law for some types of business records. The Food and Drug Administration (FDA) requires records
for demonstrating regulatory compliance to be retained for 25 years or more. Patent records must
often be maintained for as many as 35 years (including filings for claim extensions). Trade secret
records (e.g., formula for Coca-Cola, for example) must be maintained until it is made public, if
ever. The FDA requires records created during development and manufacturing of implanted or
replacement body parts (pacemakers, organ transplants, and, in the future, genetic therapy records)
to be retained for at least as long as the affected patients are alive. The FDA also recently
introduced a new law that requires electronic records to be kept in addition to paper records. 6 In the
future, other federal agencies will make this a requirement as well. It is not enough for these records
merely to be retained, they must maintain their integrity and be accessible. Preserving record
integrity and accessibility can be particularly difficult since this involves the ability to view and
print an accurate and complete visual rendering of the record at any time it is needed in the future.
7
Rapid Planned Obsolescence: The Heart of the Titanic 2020 Problem
With regard to records created over the past 10 years, The National Archives faces a relatively small
problem that is the result of old technologies becoming obsolete and unavailable. Individuals and
businesses that create and drive our economy, our government, and our educational and research
institutions face a similar problem of Titanic proportions. Whether or not data integrity is
compromised during a migration (a potential financial burden in itself), a tremendous financial
burden accompanies almost all data migration. Format incompatibility results in reduced
productivity, which becomes a constant and costly problem. Even though modem technology
allows electronic records to be created, accessed, and searched more quickly than records in any
other form, because of planned obsolescence and the rapid decrease in time to obsolescence, this
same technology ensures that these records must be regularly migrated to the newest available
technologies (which are frequently unable to read the older formats). Miss some migrations and
you may lose access to critical records entirely or regularly migrate data and absorb the associated
financial loss. Neither choice is one we can afford.
6 See www.censa.org/21CFRpart 11 .html or www.21CFRpart 11 .org for extensive information on this regulation.
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A"Day-ln-The-Life" Hassles Of Migration and Incompatibility
File incompatibility is a frequent problem between old and new versions of the same software. The
two examples given here, Microsoft Office and Lotus SmartSuite, were chosen only because they
are familiar to many people. The problems described here are so commonplace that almost any
other software for creating or managing data or records could have been used to illustrate the
problem.
In the case of Microsoft Office, a file incompatibility exists between the Office95 and Office97
versions of MS-Word, which for simplicity we will call Word 95 and Word 97. 7 Although the price
of the software upgrade was only $80, the incompatibility creates many hidden costs in the version
upgrade. The hidden costs arise from the loss of productivity as users unsuccessfully attempt to
migrate documents from Word95 to Word97. More hidden costs arise from the need to train
employees on all the differences between the two product versions, as well as strategies for
migrating documents. Many other hidden costs exist depending on the context of the upgrade, e.g.,
personal versus business. Hidden costs associated with software upgrades are usually many times
greater than the actual cost of the software.
For example, when Word97 was released, documents created and saved in a Word97 format could
not be accessed via Word95. Thus, when a Word97 user sends a Word95 user a document, the
latter is unable to open, view, or print the Word97 file. If the Word95 user is unable to speak
direct.ly to the W o r d 9 7 user, all work stops until she may do so. When the Word95 user and the
Word97 user manage to connect, they may quickly discover the problem is due to the fact that they
are using different versions of Word, if they are experienced or sophisticated users. The Word 97
user then resaves the file in the older format and resends it. If the users are inexperienced, it may
take them a long time to discover what the problem is and how to solve it. Additionally, even
though the Word97 user saves the document in the older format, if the document contains new (and
incompatible) formatting commands, some parts will look jumbled when it is opened in Word95.
The Word'95 user must again contact the Word'97 user to determine whether or not the document's
appearance is correct. If one or both of the users are experienced or sophisticated, they may quickly
realize that the new formatting will either need to be removed or manually reproduced in the old
format. If they are not sophisticated users, they may not be able to recognize the source of the
problem, or they may conclude that the document file is corrupt and must be entirely regenerated
from a much older version, or even from scratch. In any case, manually reformatting even part of a
document can be tedious and time consuming if the document is complex and uses many styles of
headings, tables, and figures. When the Word'95 user believes the reformatted document is finally
complete and correct, the document is generally faxed to the Word'97 user for a final review. At
this point, after spending anywhere from a few minutes to several hours on solving problems due to
incompatible format issues, many users will choose to fall back on the reliability of the older
technology.
Incompatibility problems were very common for the first two years after the release of Office'97.
Many large organizations have a policy of not upgrading to newer versions of software for many
months or even years after new versions of software are available in order to avoid bugs and other
7 The version of Word released with Office95 was actually Word version 7.0. We refer to it as Word95 to avoid
confusion between MS-Word version released with Office95 and MS-Word version released with Office97.
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costly problems inherent in popular software. Unfortunately, the longer a company waits to
upgrade, the longer they and the organizations they work with must suffer because of
incompatibility problems. Sometimes vendors will create point solutions to these problems but fail
to announce that such solutions are available. For example, about 18 months after the release of
Office97, one of the researchers of this article called Microsoft to find out if a Word'97 to Word95
translator was available for Word95. After paying $35 for the technical support call, the author was
informed that a file translator was recently posted on the Microsoft Technical Support website. To
the authors' knowledge -- confirmed by polls of fellow users of Word'95 -- no notification of the
availability of this file translator was ever sent to customers.
Often, some people assume that with enough finagling, it is possible to work around the
incompatibility problems between older and newer formats, but this is not always the case.
Complex documents, particularly those that include graphics and tables may convert very poorly,
some not at all, and some may actually become corrupted. For example, it is not uncommon for
pointers (invisible electronic markers that indicate what should be displayed where in a document)
to be misinterpreted, damaged, or destroyed in the process of opening a file in a different format.
Such corruption often results in the total loss o f formatting and/or content.
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Economic Model of the Users' Cost to Upgrade from Office'95 to Office'97
The following economic model is based on a population of 100,000,000 users at work. One
hundred million was chosen because in 1997, Microsoft claimed to have sold at least 80 million
copies of MS-Office. After only two years, this would add up to more than 100 million users. 8
For calculations, it is assumed that each user work 37.5 hours per week, 48 weeks per year.
During the first year after the software upgrade's availability, it is assumed that 10 minutes was lost
per week per user. This is an extremely conservative number; many users reported losing much
more time before recognizing and learning to solve the problem -- even fairly sophisticated users.
Year 1 - Time Lost
Description
10
Minutes (10 x 48 weeks) =
480
(480 x 100,000,000 users) - 48,000,000,000
Minutes Lost on Average per Week
Minutes Lost Annually per User
Minutes Lost Annually by Total User Base
i
Years
(48,000,000,000 + 108,000 v) --
444,444
Work-Years Lost by Total User Base
v 108,000 is the number of minutes in a work-year (37.5 hrs/wk * 48 wks/yr)
In the second year after the software upgrade's availability, it is assumed that time lost was reduced
50% because people learned to recognize and solve the problem faster, and more people have
upgraded to Office97. Thus, during the second year each user lost an average of 5 minutes per
week. This means that 222,222 work-years were lost by the total user base in the second year.
Similarly, in year 3 after the software upgrade's availability, it is assumed that the time lost due to
incompatibility problems was only 1 minute per week per user, and 99% of users have upgraded.
As a result, 44,444 work-years.were lost by the total user base during the third year.
The cumulative time loss derived from adding the conservative numbers above is astounding. For
every 100 million users, a conservative estimate of 711,110 total work-years 9 were lost during the
first three years the software upgrade's availability. To translate these work-years into United States
dollars, the total work-years is multiplied by cost per employee per year. A cost of $110,000 US
l0
dollars fully-loaded annual headcount cost was selected.
Thus the total labor cost due to this
particular file incompatibility problem was $42 billion dollars.
This cost of lost labor does not include the upgrade purchase price, which is also substantial. To
calculate the cost of the upgrade itself, the model assumes that for a group of 100 million users, it
assumes 25% of these users upgraded during year one, 75% of these users upgraded by the end of
8 A full spreadsheet model with the variable model parameters is available for download at www.censa.org.
9 A work-year equals the amount of work one person would do in one year when working. In this example, we use 37.5
hours per week, 48 weeks per year.
~0Fully-loaded annual headcount cost means the total annual cost of an employee to an organization. This include
salary, benefits, other compensations, and other expenses on a per employee basis (utilities, rent/mortgage, office
supplies, etc.). Fully-loaded costs range from $70,000 for low-wage earners in small organizations to over $225,000 for
high-wage earners in large organizations. A median of $110,000 was chosen as a conservative annual headcount cost.
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the year two, and 99% of these users upgraded by the end of the year three. At a cost of $80 per
upgrade, $6 billion dollars were spent the first year, $2 billion dollars were spent the second year,
and $80 million dollars were spent the third year after availability. This means that the total cost of
the software upgrade to the user base was about $8 billion dollars.
Adding the lost labor costs and upgrade purchase costs, for 100,000,000 users, the upgrade from
Office'95 to Office '9 7 cost the user community $51 billion dollars.
Unfortunately, the actual cost of incompatibility is much higher. For example, this model assumes
each user lost 10 minutes per week the first year, 5 minutes per week the second year, and 1 minute
per week the third year. Many users report having lost three or more days in a week on multiple
occasions to resolve incompatibility problems. Similarly, although this model is based on the
estimation that 99% of users have upgraded by the end of the third year, recent surveys still suggest
that many large companies (as many as 7%) still have not upgraded from Office 95 to Office 97.
Additionally, while the model indicates a lost productivity cost of roughly $43 billion dollars, this
does not reflect other related costs such as retraining (which is more difficult to estimate).
Retraining costs are a significant cost of using software upgrades, sometimes requiring less
sophisticated users to take new training courses. To include training costs, we would need to
include course costs, training time costs, and lost productivity costs. Since the total cost of training
includes course training costs, training time, and lost opportunity costs, the actual costs could total
several times $43 billion dollars.
End users lose this time and money in business and at home. To avoid or solve the incompatibility
problems, users are often forced to buy the latest release of a product. One would hope that such
incompatibility problems are never intentional. Yet upgrades provide substantial revenues for
vendors. So, from a vendor's point of view, incompatibility and rapid planned obsolescence are
both ways to drive customers to upgrade.
Although in this research report, Microsoft Office is used as the example for modeling costs of
planned obsolescence, similar analysis of any other commonly used software would yield similar
results. For example, Lotus SmartSuite also produces documents for business communications. A
Lotus representative reported that at least 25,000,000 copies of Lotus SmartSuite had been sold by
late 1999. ~ Lotus claims that the Lotus SmartSuite market share is 10%, which would mean at
least 250 million office automation suites total have been sold in recent years, including Microsoft
Office and Corel's PerfectOffice. Another commonly used software, Lotus Notes, has sold at least
40 million copies total, with an annual sales "run rate" of at least 10-15 million more per year.
Taken cumulatively, the numbers we input to test the economic model above are very conservative.
The model was developed primarily to show how to establish some minimum costs of rapid planned
obsolescence to society. The total number of word processors sold is probably in the many
hundreds of millions, so the actual costs are undoubtedly larger than thoSe given here. When the
other types of software packages are counted, the costs of rapid planned obsolescence could
skyrocket to trillions of dollars by the Year 2020.
11Collected from a Lotus Worldwide Public Relations representative on 12/15/1999.
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Many software proponents would argue that instead of focusing on lost productivity and lost
opportunity costs, users should really focus on the productivity gains possible from having more
powerful office automation tools. Productivity gains from these automated tools are unquestionably
great. It is possible to develop models to calculate financial benefits gained from improved office
automation tools. Indeed, such economic models were developed years ago for word processors
and spreadsheets, and have been relegated to the annals of business history No one would never
think of going back to manual typewriters, scissors and tape, and correction fluids instead of
automated word processing tools. The models and facts given here are meant to inspire critical
consideration of business practices that routinely thrive on rapid planned obsolescence. It is
important to expose some of the actual costs of planned obsolescence. There should be more and
better automation-- not less -- with planned preservation available as a standard option without
extreme additional cost.
10 Breaking The Status Quo: Giving Data Control Back to Its Rightful Owners
While moving data between two different versions of the same software can present migration
issues, this problem pales when compared to the problems encountered when data must be moved
between different products or applications. An outdated mentality persists among software vendors,
that of "keeping customers by holding their data hostage." In order to create and maintain captive
market share, vendors frequently define their products as the center of the data universe. In a
capitalist economy, this is one way to create a successful business. Software vendors whose
products are not the center of the data universe strive to compete and re-center the data universe
around their own products. One way for a vendor to achieve or maintain this goal is to make it easy
to import data into their software, but make it difficult to export complex data to other systems.
Data export and external access to important system-level data structures such as file structures and
database indexes are usually left as an "afterthought" for the next major software version (if they are
added at all). However, more and more businesses increasingly rely upon many different systems to
accomplish their business processes and goals. Thus, standards for data sharing and access across
system space and time boundaries are becoming urgent priorities.
Obviously marketing reasons exist to prevent sharing data too easily. If data may be easily
exported, then customers can more easily migrate to competitors'products. For this reason, vendors
rarely dedicate their limited resources to solving export problems. Instead, niche vendors and
integrators respond to these customers by providing costly custom data import and export and
conversion utilities. This creates another industry that provides a continuing stream of revenue for
smaller vendors and integrators as the larger vendors introduce regular upgrades and enhancements.
Because most of these data integration and conversion solutions are not simple for end users to
deploy or use, users must pay highly-trained, usually expensive, consultants to integrate their
applications and ensure that users understand how to use them. The result is a set of endemic
software industry practices that ensure that while the data created, manipulated, and analyzed by
computer software belongs to the consumers, the long term access to that data is controlled by the
vendors who sell the software (thereby locking up the customer base).
These problems are enhanced by the fact that vendors regularly leave the marketplace in one way or
another: businesses fail, old product lines need to be retired, or a new product line is created without
a practical and easy way to migrate from the old to the new product. Other vendors, in an effort to
grow powerful in the marketplace, produce newer, more innovative systems before data is migrated
from existing systems. Then they will provide easy import capabilities, with poor export
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capabilities. In these cases, time and money must be spent developing custom application and data
migration applications, which are quickly out of date, and may only be useful for one migration.
The problem is increasingly serious because we as a society are increasingly dependent on
computer systems that fail to address major record keeping issues.
The alternative today is if you want records that you create and own to be accessible long-term
without continual expense, it is your financial burden to design or buy your own system to make
your data system-independent, even though it was your data to begin with. However, by taking the
records out of proprietary formats, the integrity of the data is frequently lost, so the risk is high that
you could lose the purpose of your investment anyway.
Historically, it is easy to see the trends that led to these practices. Enormous amounts of time,
money, and expertise were necessary simply to solve the technical problems standing in the way of
meeting basic business needs. Today, many of the original problems have either been solved or
new tools exist to help solve existing problems more quickly. A more effective way of building and
keeping a large consumer base is to begin to focus on the gander needs of consumers, including
long-term data access. Vendors can developsuccessful marketing strategies around providing the
best customer quality and value, rather than proprietary tricks to hold customer data hostage.
With better infrastructure technology standards, data access will get easier and more open. The
World Wide Web has the potential to revolutionize attitudes and behaviors about data ownership
more then anything else in history. Many infrastructure standards exist such as the eXtensible
Markup Language (XML), Java, JavaBeans, Lightweight Directory Access Protocol (LDAP),
Common Object Request Broker Architecture (CORBA) services, and the proprietary Microsoft
standards Common Object Model (COM) and ActiveX, MAPI, Open Database Connectivity
(ODBC), and others. The problem is that these protocols change very quickly relative to the time
scales of large organizations.
With the newer protocols, such as XML and Java, the "Browser Wars" are still raging. The
Browser Wars are where vendors such as NetScape, Microsoft, Oracle, IBM, and others have
created their own proprietary extensions to the HTML and Java languages ostensibly to enhance
them. The net results have been improved protocols, with minor incompatibilities that make users'
lives difficult, make website developers' lives miserable, and make HTML and Java far too unstable
to be suitable for long-term data preservation and access applications.
Vendors' most often-cited reasons for not supporting particular standards are:
1) the cost (It takes scarce time and resources away from competitive features to define and
implement standards. Standards are always a cost center, never a profit center for vendors.),
2) poor current acceptance (no one wants to be first to say goodbye to their proprietary
technology),
3) short lifetime of most standards (especially if no one really commitsto them!),
4) the need to "enhance" standards ("our ideas are better" or "there were always some unacceptable
compromises made"),
5) the Not-Invented-Here syndrome (everybody wants to be the standard, nobody wants to follow
someone else's standard.)
..
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These reasons are sometimes legitimate; frequently they are simply competitive smokescreens. The
persistence of these reasons put the onus on large corporate customers to push vendors to support
existing and emerging standards for long periods of time. Buyers must finally make design for
long-term preservation and access and interoperability into high-priority, baseline requirements for
all new IT products for electronic records or knowledge management. Part of this Call To Action is
for large organizations -- government and industrial -- to push for standards by "voting with your
feet" to stop purchasing IT products that do not support long-term preservation and access of
electronic data and records in application-neutral, open and published formats.
11 Avoiding the Icebergs" The Itinerary Has Been Changed
The Titanic 2020 problem is likely to get much worse before it gets better. Universities do not
routinely offer courses or curricula on how to design digital systems for long-term preservation and
access to data or records. 12 An entire generation of computer science and engineering professionals
needs to be taught basic designs for preservation, not just innovation at the expense of history.
Some records are too valuable to entrust to today's computer systems. Commercial products sadly
address only a "long-term" horizon of a few years. They most certainly do not include built-in
capabilities for their own replacement. The mind shift called "paper minds to electronic records"
must still take place to move us all the way into the Information Age.
Practicing information technologists must develop a fuller appreciation of the disciplines and
practices of record managers, archival scientists, and library and information scientists. These
professionals are the guardians of corporate accountability. They are also important gatekeepers for
intellectual capital, and levers for getting the most out of it. Information technologists must design
acceptable technology solutions that meet the needs of these communities of business professionals.
There is an exploding need for universal digital archiving systems and formats. Universal formats
for each data type (e.g., motion pictures, audio, dilgital certificates) are badly needed by many
communities. The World Wide Web Consortium 3 is sponsoring work to harmonize semantics for
Web-based information that will apply generally to as many communities as possible. However,
competitive wars are expected to stretch out real semantic unification for information for many
more years. In the mean time, we badly need universal information container formats that allow
high-quality publishing of collections of dynamic information collected from many sources. An
electronic legal record is compilation of data that is recorded, signed, and sealed in an immutable
form, typically in the form of documentary evidence. Thus, one of the greatest needs for electronic
records has been format standards for publishing compound documents that can include text,
graphics, numerical data, tables, etc.
The storage format that comes closest to a universal standard for high-quality publishing is Adobe
System's Acrobat Portable Document Format (PDF). ~4 PDF is a "container format" that permits
capture, publishing, sharing, and preservation of complex compound documents with embedded
12 Research and codification of the rules of system design and engineering for long-term preservation and access to
electronic records are underway now in an international collaborative research project called the InterPARES Project.
Courses on this subject are being developed and taught in a few leading universities and industry now. See
www.censa.org/industry-interpares,
www.interpares.org, or www.is.gseis.ucla.edu/us-interpares
for more information.
It will be a few years before these principles are routinely embedded in higher education.
~3 See www.w3c.orR for more information on the World Wide Web Consortium.
w
14 For more information on Acrobat and PDF, see www.adobe.com/products/acrobat[adobepdf.html.
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digital audio, video, and other dynamic data types. PDF permits communication of these published
documents across all major types of computer platforms (MS-Windows, Apple Macintosh OS, and
many flavors of UNIX, including Linux) and across time. Although it does not work for all types of
data, it is good enough for archiving of many types of high-quality digital documents and data.
Extensions to PDF or other products still need to be developed to support permanent archiving of
large commercial databases, spreadsheets, and other specialized scientific and technical data sets.
An explanation of the terms "forward compatibility" and "backward compatibility" will help to
clarify the following discussion. "Forward" or "backward" always means relative to a software
version or to a file format version. Backward compatibility of software means a newer software
version can read and process files created by an older software version. Forward compatibility of
software means an older software version can read and process files created by a newer software
version. People most often desire backward compatibility of the software to read and process older
files, since the software is continually updated. Forward compatibility of the software is less
frequently needed, only by people who fall behind in software versions, e.g., trying to read an MSWord97 file with MS-Word Version 7.0 ("Word95).
i
\
~
•
Point
Translator
Solutions
General
Solutions
~
•
~
•
""
j
~
~
•
J
•
i
Y
The diagram above illustrates the difference between long-term, general solutions and "point
solutions" in time. Point solutions rely on translators to convert from an older version to a newer
version of a file format. MS-Office includes file converters to translate nearly all of its older file
formats into the latest file format, and vice versa, obviously with a loss of features that did not exist
in the older formats.
General file format solutions can be read directly with any newer software versions, without using a
translator, and if they are high-quality general solutions, without generating errors. General
solutions are more reliable than version-to-version file translators, because version-to-version
incompatibilities can cause critical information to be lost, especially embedded graphics and links,
table formatting, and other software version-specific details. However, general solutions are much
harder to create, because IT changes so fast and competition is so fierce. More important, it
requires a tremendous amount of foresight and creativity to create products that evolve gracefully in
such a fast-moving world, plus a firm business commitment to long-term compatibility. Relative to
lower-tech industries, the IT industry per se is very young, immature, unstable, and competitive.
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800 West Cummings Park, Suite 5400, Woburn, Massachusetts 01801 USA- Web: www.censa.org
This makes it difficult to create general solutions with high-level of fidelity and interoperability that
the leading IT vendors agree to support for long periods of time. With a few notable exceptions,
vendrrs have perceived file and data formats as a competitive weapon to use against competitors
and customers.
Adobe Systems (San Jose, CA) is an example of a company with a truly unique philosophy and
commitment regarding long-term product compatibility. Adobe has a broad and public Commitment
to provide 100% backward compatibility of the PDF format for at least the next 25 years. No other
software vendor has such a forward-looking philosophy and commitment to its customers. An
important business reason for this commitment is that Adobe is beholden to the publishing industry,
which has standardized on Adobe's PostScript language and many of Adobe's other multimedia
publishing products. PDF is a new and improved but compatible version of PostScript, that also
supports high quality publishing on the World Wide Web. The publishing industry simply cannot
afford to retool every few years. Publishers must be able to access, view, and print their archived
documents and books on demand for many decades to come.
The publishing industry's practical need for a general solution that has stability and backward
compatibility was recognized early by the United States Internal Revenue Service, the Food and
Drug Administration, the Environmental Protection Agency, the Patent and Trademark Office, and
many other government agencies. More than 140 government agencies worldwide have adopted
PDF as their standard for document submission and archiving. Many industries have followed the
lead of these government bodies and adopted PDF, primarily because it makes it easier to do
business internally and with the government.
The Collaborative Electronic Notebook Systems Association and its end user member companies,
which include several large pharmaceutical corporations, adopted PDF in 1997 as the preferred
format for document communication and publishing and permanent storage of electronic records for
three specific reasons:
1) PDF's is the defacto government standard for document publishing and archiving;
2) PDF's high quality rendering capabilities for multimedia publications; and
3) Adobe's long-term commitment and long track record for successful and complete backward
compatibility, going all the way back to the version 1.0 of PostScriptreleased in 1984.
The third point is the most important from a practical point of view. PostScript printers of 2000 can
still faithfully render files created in PostScript Version 1.0 format. This track record of 15 years
speaks volumes in a world where Web years are measured in weeks or months on the calendar.
With extensions to support XML, PDF can apply to all types of data published on the web a n d
elsewhere, and for exchange and archiving of more specialized scientific and technical data types.
The most recent release of PDF added security features to support signing and witnessing of PDF
documents, allowing users to create self-contained, portable electronic records. Finally, an army of
third-party software developers is using the open and published PDF format to extend and apply
PDF to different applications and niche markets. PDF has a long future ahead of it.
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12 The Die Has Been Cast for 21 st Century Information Technology
Adobe has proven to business leaders, IT professionals, and governments worldwide that stability
by design, coupled with rapid innovation are not only possible, but profitable too. Most important,
with Adobe's commitment to long-term stability and support, the die has been cast for end user's
expectations of the IT industry in the 21 st Century. This report does not mean to single out Adobe
for benevolence or philanthropy -- clearly the company has benefited economically from its longterm commitments. In every age of technology there have been companies that have built fortunes
by getting into new areas of business early. In the near future, suppliers who commit to stable,
flexible and open technology designs for electronic records and data systems will have a huge
competitive edge. They will profit over those who choose to maintain a perpetual blind eye to the
need for stability in at least one part of their technology design -- the data or records owned by their
customers. In the future, the stability of digital records, whether corporate, government, or
personal, must be measured in decades to centuries rather than web years.
Innovation does not have to come at the expense of the integrity of our data or records over time.
Information technologists are among the smartest and most creative people on the planet, clearly
capable of creating flexible technologies that are extensible far into the future and backward
compatible. Stability, flexibility, extensibility, and backward-compatibility are not opposing or
incompatible requirements but simply additional business constraints on present and future
electronic record and data storage technologies, products, and systems.
13 The Ship Has Left the Dock
The Titanic was designed to be the biggest, most technologically advanced ship of its time, and
indeed it was. No one would argue that the ship failed to meet the expectations of the passengers
who paid enormous sums of money to stay in her staterooms. But the fact that the ship appeared to
set a new standard against which all other ships would be measured inspired too much confidence in
it creators. They did not believe it necessary to make sufficient provisions for the safety of their
passengers. Of all the questions about the Titanic's tragic demise, a particularly haunting one
stands out: would the passengers have booked passage if they had known the boat had no sufficient
exit strategy?
Like the passengers of the Titanic, it is easy for users of computer systems to believe in the
marketing messages of vendors and become overconfident in the safety of their data and records.
However, experience has given most modem users the chance to understand what passengers of the
Titanic could not, that within the current, albeit often-impressive solutions lie dangerous pitfalls that
cannot be ignored. Perhaps the market dynamic that once allowed Red Star Line to create the
Titanic and now allows computer businesses to create systems used by millions of users shouldn't
be broken. But the disaster that visibly looms in our future cannot be ignored. If the Titanic had
had enough lifeboats for all her passengers, she would perhaps still be remembered as the biggest
and most advanced ship of her time. She would not have become symbolic of the inability of man
to recognize and plan for his own fallibility. Like the Titanic, current computer systems are in part
a result of man's unwillingness to recognize and address the shortcomings of an industry that has
mushroomed both technologically and financially. If this problem is not addressed now, in
approximately 20 years, the Titanic may be replaced with a new icon of disaster.
148
"Solving the Problems of Electronic Recordkeeping and Archiving
for Scientific, Intellectual Property Protection, and Regulatory Applications"
By Dr. Rich Lysakowski, Executive Director,
The Collaborative Electronic Notebook Systems Association (CENSA),
800 West Cummings Park, Suite 5400, Woburn, MA 01801
e-mail: [email protected] -- web: www.censa.org -- phone 781-935-9600
Electronic records are a new medium for scientific and intellectual property applications.
Scientific and intellectual property records are the highest value of all types of records
because of their economicand business impact. Intellectual property records provide
evidence of invention. They are used to grant protection of commercial and product
rights in markets around the world. These rights provide legal remedy in case of the
theft of ideas, and grant a many-year period of exclusive rights for inventors to profit
from their ideas. Thus, they are the primary basis of incentives for companies and
individuals to invent new things and share them with the world at large. A single record
of invention can mean the difference between winning or losing rights to a multi-billion
dollar product patent. Thus the motivation for inventors to falsify records can be strong.
However, using paper records, an elaborate and strong system of protection has been
developed over the past 400 years. The dominance of paper for primary recordkeeping
is being challenged by computerized systems to the point where it is obvious that paper
is already obsolete. So much data is being generated by computers now that it is no
longer practical to use paper for primary recordkeeping. Many data types (video, audio,
biological and chemical data, and other dynamic data types) have no practical paper
equivalent. Finally, paper is difficult to search and share. Thus, replacing paper as the
default storage medium for records is a major imperative for organizations worldwide.
Replacing paper as the medium for recordkeeping requires that equally reliable and
trustworthy systems of electronic record protection be developed. The problems
associated with protecting these high-value records in electronic form are large. Legal,
regulatory, technological, business, scientific, sociological, and other issues must be
addressed so people are as comfortable with electronic systems as paper-based ones.
CENSA, the Collaborative Electronic Notebook Systems Association, is a global trade
association focused on solving problems associated with successfully using electronic
records in lieu of paper records. CENSA is working in partnership with key industry
suppliers and government agencies to collaboratively solve our common problems.
CENSA is primarily dedicated to automation market development for research and
development R&D organizations. CENSA sponsors major research and development
programs with the purpose of creating and populating new markets with products that
meet end user needs faster than traditional market processes now allow.
This paper will discuss the problems of replacing paper with electronic records, and
CENSA's programs to solve those problems quickly with a unique stepwise approach
using market and product development programs.
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" S o l v i n g the P r o b l e m s o f E l e c t r o n i c R e c o r d k e e p i n g a n d A r c h i v i n g
for Scientific, I n t e l l e c t u a l P r o p e r t y Protection, a n d R e g u l a t o r y A p p l i c a t i o n s "
Table of Contents
P R O B L E M S A N D S O L U T I O N S F O R P R O T E C T I N G I N T E L L E C T U A L P R O P E R T Y ...................... 3
1.1 PROBLEMS WITH CURRENT SYSTEMS FOR PROTECTING INTELLECTUAL PROPERTY ............................ 3
1.2 BUILDING "COMPLETE SYSTEMS" FOR ELECTRONIC RECORDKEEPING AND ARCHIVING ...................... . 5
E - R E C O R D S - AN E M E R G I N G M A R K E T T H A T N E E D S TO M A T U R E ...........................................
6
A C C E L E R A T I N G E R E C O R D S M A R K E T E V O L U T I O N ....................................................................
7
C E N S A , T H E A U T O M A T I O N M A R K E T D E V E L O P M E N T A S S O C I A T I O N ......................................
8
4.1 THE INDUSTRIAL MEMBERS OF C E N S A ............................................................................................
8
4.2 THE GIIG ON ERDAS - GOVERNMENT ORGANIZATIONS WORKING WITH CENSA: ............................ 9
4.3 GOVERNMENT MEMBERS OF THE GLOBAL INDUSTRY-INTERAGENCY GROUP ON ELECTRONIC
RECORDKEEPING AND DIGITAL ARCHIVING SYSTEMS (GIIG ON ERDAS) ...............................................
10
C E N S A ' S R O L E IN THE I N T E R P A R E S P R O J E C T ........................................................................
5.1.1
5.1.2
5.1.3
11
The Global Industry Team in InterPARES .............................................................................
11
Industries Represented Now on the InterPARES Global Industry Team .............................. 12
The Global Industry Team's View of the InterPARES Project:..
12
5.2 THE INTERPARES CASE STUDY METHODOLOGY ...........................................................................
12
C E N S A M A R K E T D E V E L O P M E N T O B J E C T I V E S A N D P R O C E S S .............................................
14
6.1
6.2
6.3
6.4
14
15
15
15
SUCCESSFUL PRODUCTS ARE A HIGHER PRIORITY THAN STANDARDS ............................................
STANDARDS MAKE SYSTEMS INTEGRATION MUCH EASIER ......................................................
........
E-RECORDKEEPING PROBLEMS ARE BIGGER THAN GOVERNMENT OR INDUSTRY..............................
ELECTRONIC RECORDKEEPING REQUIRES ROBUST AUTOMATION MARKETS ....................................
C E N S A D E V E L O P M E N T P R O G R A M S T H R O U G H 2001 ...............................................................
17
7.1 LEGAL AND REGULATORY STANDARDS FOR ELECTRONIC RECORDKEEPING AND ARCHIVlNG .............
7.2 ELECTRONIC RECORDKEEPING AND DIGITAL ARCHIVING SYSTEMS ..................................................
7.3 COLLABORATIVE ELECTRONIC NOTEBOOK SYSTEMS AND APPLICATIONS PROGRAM .........................
7.3.1 The CENS Applications Specifications Work of CENSA .......................................................
7.3.2 Electronic Notebooks Are Driving Technology Convergence ...............................................
7.4 INTEGRATED PROJECT SUPPORT ENVIRONMENTS (IPSE) PROGRAM...............................................
7.5 COMMON C E N S ARCHITECTURETM PROGRAM FOR SYSTEMS INTEGRATION.....................................
7.6 COMPONENT AND APPLICATION INTEGRATION TOOLS PROGRAM .....................................................
7.7 KNOWLEDGE MANAGEMENT TOOLS AND SYSTEMS PROGRAM .........................................................
17
19
20
22
22
23
23
S U M M A R Y A N D C O N C L U S I O N S ...................................................................................................
24
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"Solving the Problems of Electronic Recordkeeping and Archiving
for Scientific, Intellectual Property Protection, and Regulatory Appfications"
1 Problems and Solutions for Protecting Intellectual Property
1.1
Problems with Current Systems for Protecting Intellectual Property
Bound paper notebooks with sequentially numbered pages (called "recordbooks") are
used almost universally for scientific and technical recordkeeping because they are
convenient, portable, and easy to use. Recordbooks also make it obvious if a single
page is torn out of the book, or if records are altered. Recordbooks are issued to
scientists for the purpose of recording results of experimental work. In the United
States, the "first to invent" system is used, rather than the "first to file" system that is
used in the rest of the world. The issuance of patents requires that inventors prove the
original date of invention. All commercial rights hinge on this date. This rule forces
inventors to keep very good records of the original conception of an idea and its
"reduction to practice." These records are often used for litigation in patent courts.
In the picture below we see an example of the types of recordkeeping problems
encountered in R&D as a result of using paper-based recordbooks.
This recordbook is an excellent example of the many things that are broken with paperbased recordkeeping systems. The book binding is literally broken because too many
things were pasted and paper-clipped into the book. Nearly eVery type of data has
been captured into the book, including tables of data, spectral data, chromatograms,
strip-chart paper printouts, photographic images, drawings, handwritten notes -- even
chemical samples in plastic bags. If a records administrator tries to microfilm or make a
"backup copy" of this notebook, it will fall apart.
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"Solving the Problems of Electronic Recordkeeping and Archiving
for Scientific, Intellectual Property Protection, and Regulatory Appfications"
The important thing that is harder to see is how much time this recordbook took to
assemble and use. CENSA has developed and applied workflow and cost-accounting
models for the entire lifecycle of recordbooks, with an objective of measuring how much
time is spent by scientists, administrators, patent attorneys, and others who touch
recordbooks on their journey through typical R&D organizations. The time-based
models were translated into dollar costs. Conservative estimates were made for the
amount of time that can reasonably be saved with electronic recordkeeping systems
over current paper-based notebook systems.
Results of these analytical studies are shown in the chart below. The dollar equivalent
of the total time that can be saved ("recoverable time") using electronic notebooks is
shown charted versus the number of notebooks used by an organization in a year.
"Recoverable" which means this time can be returned to the organization after the
electronic system is in place. This savings translates into $80,000,000 US dollars
(110,000,000,000 Lire) for an organization in a regulated industry that issues 2500
notebooks annually. The slope of this line show that $33,000 US Dollars per notebook
issued annually are recoverable.
Recoverable US Dollars Lost
$ 80,000,000
$ 60,000,000
$ 40,000,000
$ 20,000,000
300
1000
1500
2500
Number of Notebooks Used Annually (Per Company)
These result do not account for additional gains in individual and corporate productivity
from searching and sharing information more easily in electronic form, or the benefits
from making collaboration and knowledge knowledge management much easier. It also
does not account for highly talented scientific resources that can be used for more
creative activities and new projects. These "softer" benefits are difficult to measure
using time and cost accounting methods. However, many people in industry agree that
softer benefits produce much larger financial returns than those based on simply time or
cost savings. Even without measuring softer benefits, we see a large enough return on
investment to justifies automating recordkeeping in R&D.
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"Solving the Problems of Electronic Recordkeeping and Archiving
for Scientific, Intellectual Property Protection, and Regulatory Applications"
The additional softer business benefits come primarily from"
,
•
•
•
•
•
•
Collaborative knowledge sharing and management
Cut lost opportunity costs of inaccessible records
Better decision-making processes
Not repeating experiments and other work due to lost information
Better, faster, and easier litigation
Reducing errors via better quality data entry
Performing quality assurance more easily
With these benefits in mind, we must understand some of the requirements for building
credible electronic records systems.
1.2 Building "Complete Systems" for Electronic Recordkeeping and Archiving
"Complete systems" for reliable recordkeeping and long-term archiving have several
dimensions, including legal, regulatory, scientific, technological, business, and
sociological dimensions. Each of these dimensions have both technological and nontechnological components, which are listed below.
Technoloqv Components - portable electronic record formats, electronic signature
services, public key infrastructure, access controls and other security controls,
time-certification services, an audit trailing subsystem, electronic records
' management software, storage and archival repository software and hardware,
records migration subsystem, and other parts
Non-Technology Components - standard policies, procedures, and protocols for
recordkeeping, archiving, and security; training; nomenclatures and terminology
standards; and other knowledge for development, installation, configuration,
validation, quality auditing, and other standard operating procedures for routine
system operations
Early implementation barriers have been primarily legal, regulatory, and technological.
As fully electronic recordkeeping and archiving are installed and used, the scientific,
business, and sociological dimensions will be better understood. Nearly all technology
components needed to build complete technological solutions either exist now or are
being developed now. CENSA's members are developing integrated packages of
lifecycle models, policies, procedures, technological components, and training. Through
pilot projects in CENSA member organizations, the "softer" dimensions of science,
business, and sociology are being better understood now.
i
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for Scientific, Intellectual Property Protection, and Regulatory Applications"
2
E-Records - An Emerging Market That Needs to Mature
Electronic Recordkeeping Services ~ (ERS) software is a new type of automation system
used in R&D and at the corporate level. ERS is a distinct class of software, distinct from
the traditional records management (RM) software and document management system
(DMS) software. RM products are typically only for indexing and scheduling paperbased records. DMS products are for managing documents in electronic form needed
for current business operations. DMSs typically do not manage "records" needed for
many decades. ERS, RM, and DM markets have traditionally been distinct. However,
as DMS vendors add RM functions to their offerings, and as RM software vendors add
DMS products for record repositories, we are starting to see meaningful convergence.
Although convergence of these markets is starting to happen, the ERS software market
is still very "immature." Immature (new) markets are simultaneously a major problem
for end users and a major opportunity for suppliers.
The best way to understand market immaturity is to look its characteristics. Typically,
new software markets have only a few players. These are either new companies or
new entrants. An immature software market is characterized by:
•
•
°
•
•
•
•
High per user costs (many hundreds to thousands of dollars per user)
Supplier-specific solutions
Proprietary data formats and closed interfaces
High-customization costs (extensive programming required)
Low configurability, i.e., without progreamming (high cost to fit ratio)
Extensive training required for end users
User resistance to complex software
As markets evolve and mature, their characteristics change. Obviously there will be
more suppliers, but from an end user perspective marketplace characteristics change
both qualititatively and quantitatively:
•
•
•
•
•
•
•
•
•
Reasonable to low cost per user
Greater user acceptance of solutions
High configurability
Open, documented interfaces
Royality-free (standardized)interfaces
Multiple choices for all major system functionality
Multi-vendor solutions
Third-party support partner networks
Configurable solutions for organization-specific complexities
1 In this paper, the term "Electronic Recordkeeping System" includes "Digital Archiving System." This is
nontraditional usage. However, in the future, I believe that these two types of systems will merge most or
all of their functions.
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3 Accelerating Evolution of the eRecords Markets
The challenge in new markets is for buyers and suppliers to work together to accelerate
market evolution at a pace acceptable for buyers to get what they need quickly and for
suppliers to profit in the process. Electronic recordkeeping and digital archiving
systems must mature quickly enough to use in production, a basic requirement is that
they are reliable enough to meet the legal requirements for long-term recordkeeping.
This class of products must mature quickly because they are badly needed by many
types of businesses now. The technology components are mature enough now to start
constructing "whole products" or entire technological solutions that meet requirements.
But first business (buyers and vendors) must know the detailed recordkeeping
requirements and their priorities.
End users must articulate the requirements completely and quickly enough to help
vendors build "the right products." Vendors must then design, develop, and support
technology solutions fast enough to help organizations make the transition away from
paper-based recordkeeping systems. End users must understand how to apply and use
the technology solutions so that the systems they build are trustworthy and reliable.
This will surely be an iterative process that involves some learning. However,
corporations cannot afford to lose high-value records in the transition from immature
technologies to reliable systems. On the other hand, R&D organizations have
enormous and growing problems with electronic data overwhelming the capacity of
paper systems right now, so solving the problems is an urgent priority.
Corporations and government organizations are increasingly dependent on software
systems that generally are no_._~treliable from a legal perspective. Regulatory compliance
and intellectual property records are long-term records, requiring at least 25 and 35
years retention minimum, respectively. Software systems do not address major
recordkeeping design issues from a long-term perspective. Most software designers
have not thought out and addressed the system design issues from the perspective of
many decades or even centuries of electronic records retention. The long-term
perspective significantly influences system design, because it affects how record
authors and their records are authenticated and validated over long periods of time. It
also affects the designs of audit trail logs, record formats, and records indexes, which
must be media, database, and application-independent. The long-term perspective
radically affects how "permanent" archiving functions are achieved. It demands
interoperability across generations of technologies so that decades of permanance are
possible. It also demands that fuJ and foolproof migration capabilities be provided by
system manufacturers so that longer periods of record access are possible.
Traditional market forces are often chaotic and competitive to the detriment of end
users, and ultimately to vendors themselves because it slows down their progress in
achieving profitability in new market segments. To solve new market development
problems faster and with higher quality, CENSA has created a series of collaborative
programs in place to accelerate market maturity.
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4 CENSA, the Automation Market Development Association
CENSA's mission as a market development association is to accelerate progress in
automation markets. CENSA is no.._ttas a vendor, i.e., it does not sell hardware or
software products. It works to ensure that market needs are met much faster than by
traditional market forces. CENSA is focused on three primary global problem domains:
1. Protecting Intellectual Property (Patents, Trade Secrets, and Trademarks and
Copyrights, and Publications)
2. Demonstrating Regulatory Compliance in regulated industry (chemical, pharma,
biotech, healthcare, consumer products, food and beverage, computers,
software, high-tech, and other industries)
3. Evolving R&D Automation Markets and Products (Infrastructure Components,
Applications, and Integration Tools)
Market development is done via a rapid market development process. First, large End
User Members working closely with CENSA staff to specify business and system
requirements. Frequently we will identify new products that meet those requirements.
Then through combined efforts of end user members and staff, the best-qualified
suppliers are recruited to build the specified products. CENSA represents the needs of
over 90,000 R&D scientists and 750,000 employees in more than 24 organizations
operating in over 175 countries worldwide. Since late 1996, several products that meet
CENSA End User Members' requirements have been successfully developed and
delivered to the marketplace by CENSA Supplier Members.
4.1
The Industrial Members of CENSA
C E N S A End User M e m b e r s
C E N S A Supplier M e m b e r s
Abbott Laboratories (pharmaceuticals, hospital
.i
iI
Adobe Systems (Acrobat, Portable Document
products, nutritional products, veterinary products) Format (PDF), Electronic Records Creation Tools,
Graphics Arts, Document Publishing Software
Tools)
Boehringer Ingelheim (pharmaceuticals,
Beckman Coulter (Lab instruments, LIMS,
chemicals, nutritionals, and many other related
instrument interfacing systems, etc.)
products)
Bristol-Myers Squibb (pharmaceuticals,
Documentum (Enterprise Document
healthcare, consumer products)
Management System Software, B2B software,
and knowledge management)
Dow Chemical Company (chemicals, plastics,
DOXIS ("Forms Without Paper" Hardware &
and other products)
Software)
Dow AgroSciences (agricultural chemicals,
IceBreaker Communications (Design Engineers
Electronic Notebook software)
biotechnology)
Glaxo Wellcome (pharmaceuticals, healthcare)
LabSystems (Lab Information Management
Systems and Instrument Interfacing Systems)
Johnson & Johnson (pharmaceuticals,
Mantra Software (Lab Data Reporting and Lab
healthcare, medical devices, etc.)
Warehousing Software)
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CENSA End User Members
CENSA Supplier Members
Monsanto Life Sciences (pharmaceuticals,
biotechnology, and related life science products)
Warehousing Systems Software)
No;cartis (pharmaceutical, agrichemical,
chemical, medical devices, etc.)
Pfizer Pharmaceuticals (pharmaceutical,
veterinary product, chemical, healthcare)
Procter and Gamble (consumer products,
healthcare, pharmaceuticals)
Purdue Pharmaceuticals (pharmaceuticals)
Rohm and Haas Company (specialty chemicals,
adhesives, electronic chemicals, salt)
UOP, LLC (chemical catalysts, catalytic
processes)
4.2
Management Sciences Associates (Data
OpenText I iRIMS (knowledge and document
management, Records and Information
Management Software
Oracle (Database management systems, web
development tools, and applications for many
vertical markets
NetDelivery I Coastek (Time-Stamping Services)
ScripSafe (PatentPad security paper products)
US Department of Engergy's National Labs
(run by Battelle Laboratories)
The GIIG on E R D A S - Government Organizations Working With CENSA:
The "Global Industry-lnteragency Group on Electronic Recordkeeping and Digital
Archiving Systems" (GIIG on ERDAS) is a proactive problem-solving partnership of
government and industrial organizations focused on solving our common problems with
long-term electronic recordkeeping and archiving systems. The primary GIIG
deliverables are detailed requirements, reference models, policies and procedures, best
practice guidelines, and other items needed to build and operate "complete systems."
GIIG membership is limited to government agencies and industrial partners who commit
required resources to the GIIG teams to solve the problems defined in the GIIG charter.
GIIG Charter: The GIIG is a partnership of government agencies and industry with a
purpose to develop and recommend principles, models, requirements, policies and
procedures for managing, preserving and accessing electronic records and information
created in R&D projects.
Many governments now have mandates and initiatives for paperwork elimination and
increased efficiency. Many US government agencies (FDA, EPA, PTO, and others)
have goals to conduct business fully electronically by 2003 at the latest. Automation of
internal recordkeeping and archiving functions will facilitate much greater efficiencies.
Recordkeeping is also a critical piece of infrastructure for achieving accountability in
electronic commerce transactions among government agencies, citizens, and industry.
Automated recordkeeping will undoubtedly increase the quality of the recordkeeping
process itself, and provide greater access to historical records of government activities.
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To achieve these objectives, and bring about "digital government," a high level of
consistency of processes and technology approaches will be needed. Without a high
level of consistency-- and eventually full interoperability-- such initiatives will be
severely hampered. Incompatibility problems could cause countless man-years of lost
productivity, as people struggle to exchange information and suffer the daily, neverending hassles of converting data, documents, and records. Valuable records could be
lost, with inestimable consequences. Standardization in the near term, and formal
standards as time permits, offers the best path to achieve the required consistency,
while meeting the urgent demands to automate recordkeeping right away.
Standarization of processes and technology approaches will pave the way for
automation of the recordkeeping and archiving functions. However, standardization of
critical business functions is a difficult process that requires a multiyear commitment of
expert resources. The GIIG is providing many experts with a focus on specific
deliverables, outlined in the section below on Legal and Regulatory Program
Deliverables. The GIIG is critically important because this problem is so big that no
single government or industry can or should solve it alone. By working together,
industry and government will bring together the required resources to anticipate and
proactively resolve the potentially huge interoperability issues in a reasonable amount of
time, before they become very serious problems.
4.3
Government Members of the Global Industry-lnteragency Group on
Electronic Recordkeeping and Digital Archiving Systems (GIlG on ERDAS)
Key government agencies involved in the GIIG on ERDAS are:
United States - Food and Drug Administration (FDA), Environmental Protection Agency
(EPA), Patent and Trademark Office (PTO), National Archives and Records
Administration (NARA)
•
Canada - HealthCanada, EnvironmentCanada, National Archives of Canada
•
Europe - European Patent Office (EPO) and the Office of Economic Cooperation and
Development (OECD)
•
Japan - Patent and Trademark Office (PTO), Ministry of Health, Ministry of Environment
The final objective of the GIIG is standards for electronic recordkeeping and archiving
processes and technology approaches. For more information on the GIIG and its
Delivereables see the website at www.giig.org.
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5 CENSA's Role in the InterPARES Project
InterPARES is a group of the leading scholars from around the world dedicated to
researching the issues of long-term preservation to authentic electronic records.
CENSA is working with many academic institutions and national archives via the
InterPARES Project (www.interpares.org). The goal of InterPARES is to use the tools
of archival science and diplomatics to develop the theoretical and methodological
knowledge essential to the permanent preservation of electronically generated records.
On the basis of this knowledge, the InterPARES researchers intend to formulate model
strategies, policies and standards capable of ensuring their preservation. CENSA's role
in InterPARES is to represent the needs of global industry, to help the InterPARES
teams understand the issues and problems being experienced in industry, to provide
industrial test beds for testing the ideas and tools as they are being developed, and to
establish practical solutions to the problems identified during the research. As
InterPARES bears fruit, CENSA will help to develop the results into standards that can
be applied by industry worldwide.
5.1.1 The Global Industry Team in InterPARES
The Global Industry Team in InterPARES represents the interests of companies that
have globalized their businesses and must approach solutions from a global point of
view, not just the point of view of a national, multinational, or international business. A
global business has many unique and distinct requirements for harmonization of
processes, laws, regulations, and results. These requirements impact the construction
of automated systems used to support global operations. The cost of maintaining
separate national versions of automation systems is prohibitively high. Corporations
need consistency across national and industry boundaries to help reduce the costs of
doing business globally.
InterPARES is doing the cutting-edge academic research needed to articulate basic
problems and perform case studies with current and futuristic electronic records
systems. InterPARES has an objective of creating model policies, procedures, and
academic standards for long-term preservation and access of electronic records.
CENSA is leading global industry in the InterPARES Project to provide additional
leverage to industries, governments, and academic institutions. CENSA believes that
having leading international experts working on the research teams and representing
their national interests will help to create consistent viewpoints and solutions that are
shared internationally. CENSA brings a strong sense of urgency to the project. CENSA
also brings the need for the final work products to share consistency across national
boundaries. We cannot afford to have incompatible models from which national
standards are derived. What we need soon are international standards for electronic
records that can be migrated reliably (from a legal point of view) over countless
generations of technologies. InterPARES provides truly international perspectives that
will help make such eventual standardization much easier.
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5.1.2 Industries Represented Now on the InterPARES Global Industry Team
CENSA brings many perspectives and interests to the InterPARES Project. CENSA
represents many industries, including the chemical, consumer products, agricultural
products, biotechnology industry, pharmaceuticals, computer software, high technology,
and healthcare. Over time, CENSA will expand to include other industries such as
telecommunications, aerospace, automotive, and others that want to use electronic
records for very high-value records. These and other industries are encouraged to
participate on the InterPARES Global Industry Team. Interested companies should
contact the author at CENSA for more information about InterPARES participation.
5.1.3 The Global Industry Team's View of the InterPARES Project:
Electronic Recordkeeping and Archiving Systems are mission-critical business systems
that must be robust, i.e., very well-engineered. They must be reliable systems that
preserve the authenticity electronic records over generations of technology. This is not
something that CENSA expects from the InterPARES research project. InterPARES is
a research project, not an engineering project. The InterPARES deliverables are not
expected to be commercial software or hardware products. InterPARES deliverables
will be various draft models, policies, procedures, case studies, and perhaps prototypes
or concept demonstrations that industry can try in test sites. We will need to transform
the InterPARES research results into engineering specifications useful for building
commercial products. Industry does not expect commercial products directly from the
InterPARES project.
The most important InterPARES work products will be clear articulations of time-tested
principles by the leading scholars and thought leaders in archival science, and
development of research models, theories, and requirements. These models will need
to be tested in CENSA test sites. InterPARES deliverables will be definitive scholarly
and educational papers useful for organizations that wish to advance their internal
electronic records programs. Additional work products will be developed and refined as
a result of the InterPARES case studies and test site activities.
5.2
The InterPARES Case Study Methodology
The InterPARES Research Teams have decided to use a case study approach to
evaluate existing electronic records systems that have been or intend to be used for
long-term preservation and access. In particular, the case study research will assess
the problems, issues, and solutions used in the preservation and migration of electronic
records held in various types of records systems. The records systems include
academic, administrative, business, technical, and scientific records systems in a
variety of settings. InterPARES researchers are using a consistent methodology so that
results cOming back from the case studies and test sites can be normalized. A set of
documents have been developed that describe the case study research methodology in
sufficient detail to help researchers apply it.
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The InterPARES Research Methodology is a set of document deliverables containing:
1. Guidelines and procedures for how to apply the methodology so that a consistent
quality of results come from applying it
2. Templates to facilitate data collection during the case studies, with slots for capturing
the following data:
•
,,
•
•
•
•
business process description,
draft object models and metadata models,
functional models,
policies,
procedures,
and other contextual information.
3. Questions to be asked during the case studies, and the types of answers expected.
It is hoped that the questions and analysis template (implicitly or explicitly) can lead
directly to a proposed set of requirements for improved systems.
4. Links back to specific InterPARES research questions and research objectives
5. Procedures for testing the answers collected using the template.
6. Metrics for judging testing outcomes to know if or when testing has met its intended
objectives.
Applying the methodology should lead to a proposed set of attributes and
characteristics for preserving the authenticity and access of electronic records. These
attributes and characteristics will be based on the best expert knowledge available now.
The expert knowledge will evolve as a result of applying the methodology. And we
expect many confirmations of existing knowledge. If the attributes and characteristics of
"bad" systems and "good" systems are understood well enough, we should be able to
derive a comprehensive set of requirements for future generation systems for long-term
preservation and access.
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6 CENSA Market Development Objectives and Process
Now that you know about many of the member and partner organizations in CENSA, it
is time to learn about CENSA's business objectives and processes.
The primary business objectives of CENSA are to provide"
•
•
•
•
,,
•
Good software and hardware at reasonable cost
Supported products that succeed long term
Slash the cost of systems integration
Give best return on investment via the leverage of many members
Create robust R&D automation markets
Focus on what's missing in today's commercial systems
The reasons for these objectives are as follows. In R&D automation markets, software
and hardware is sold in relatively small volumes so that software prices remain relatively
high for several years after market introduction, often costing many hundreds to several
thousands of dollars per user. An important reason for this high price is that the
ultimate market size is small compared with general consumer markets, so prices must
be high initially to recover costs and make a profit. Thus CENSA, via its end user
members, is working with suppliers to reduce the costs of development and sales, and
ultimately pass these cost savings directly on to consumers.
6.1
Successful Products Are A Higher Priority Than Standards
Well'supported products that succeed long term is an important objective to both
industry and government. The scientific and technical software markets are
characterized by many startup companies. Amid the many startups, many business or
product failures happen. Industry and government cannot really afford to have business
failures in the markets for electronic recordkeeping and digital archiving systems, since
we depend on these systems to preserve our business, legal, and historical records.
Moreover, the more successful products are from the point of view of sales and support,
the more likely it is that these records will be available many years from now.
Having open or formal standards is important. However, standards with vendors who
support them poorly or not at all are not worth the paper on which they are printed.
Thus, as a first priority, CENSA is committed to ensuring that commercial products are
successful. As a second priority, CENSA is committed to ensuring that products
eventually implement formal standards or become defacto product standards
themselves.
A mistaken viewpoint exists that proprietary products are somehow inherently bad or
that standards are somehow better than proprietary products. Few people disagree that
life without standards would be very difficult. Academic arguments in favor of standards
often miss the final point that products are needed that fully implement application
functionality. Standards are a means to an end, not an end in themselves. If
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organizations do not want to be in the software development and support business, then
they must buy robust and supported commercial implementations of a standard, nearly
all of which are proprietary. Someone must be paid to develop, support, and enhance
robust, production-quality software. Software quality is a first priority to business,
because if an implementation is poor, it will be rejected by end users, whether or not it
supports standards.
6.2
Standards Make Systems Integration Much Easier
After software quality is high, then standards come into play because they make
systems integration, data portability, and application interoperability easier. Thus
CENSA's market development processes are designed to ensure that, as a first priority,
excellent commercial implementations are successfully delivered to and implemented
by CENSA End User Members. After great products are delivered -- or at the same
time if workable standards already exist-- standards will be emphasized as a way to
achieve better systems interoperability and integration. Where badly needed standards
do not exist, CENSA will work to create them.
Today the cost of systems integration is typically over 80% of the total cost of
implementing a system that is integrated with other business systems. The constraint in
automation system implementation is becoming integration. Via its Common CENS
Architecture TM, CENSA is creating a component-based standards reference architecture
with a goal of reducing the cost of integrating data, applications, and subsystems by a
factor of 10 over the next five years. This aggressive goal is necessary to meet the
challenge of the worldwide Information Technology (IT)labor shortage, estimated to be
at least 1.6 million people by the year 2003 in the USA alone.
6.3
e-Recordkeeping Problems Are Bigger Than Government or Industry
The problems of electronic record keeping and digital archiving are so large that no
government agency, corporation, or university alone has the resources to anticipate and
solve the problems. Several years ago industry recognized the magnitude of
investment required to solve them. Many companies got together and created CENSA
for industry and government to gain much higher leverage on R&D money spent in
these areas, and as a way to spread out and greatly reduce the risks of complex
systems development. CENSA offers a much larger return on investment than having a
single company or government agency fund the R&D work, and in fact makes it possible
to do exceedingly difficult work in a reasonable period of time.
6.4
Electronic Recordkeeping Requires Robust Automation Markets
A robust market is one with enough vendors to provide a sufficient number and quality
of products so that if any single vendor drops out of the marketplace, then consumers
will have good product alternatives to fill the hole left behind. Consumers need more
than one good choice for every required component in a system. More than any other
market that has come before, it is important that continous, reliable business
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recordkeeping operations are not put at risk because of technology or vendor business
failures. These records are the memory of what really happened, and the basis for
future economic and political viability of organizations worldwide. The potential legal
risks due to failure or incompatibility of technologies are definitely higher with electronic
systems than with paper systems. Poorly-designed products that hold records hostage,
endanger them with unreliable components, make migration difficult, or that
compromise record authenticity or integrity are unacceptable to attorneys.
,!
i-
Standards by themselves are not sufficient to ensure that a market is robust. Standards
are only one of many components of a robust market. Many other processes are
necessary for strong markets. Letting chaos reign is fine with other product markets
that will not have such a grave impact on our past and future. Through its market
development programs, CENSA is catalyzing the creation of robust markets to address
this legal need of the business. The CENSA standards philosophy is "where standards
exist, use them; where they don't exist, if they are important enough, create them." A
full discussion of robust markets and approaches to market development are beyond
the scope of this paper.
,i
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i x
7 CENSA Development Programs through 2001
CENSA accomplishes its objectives via applied research and development programs.
These R&D programs have a time horizon of one to four years, or until widespread
market availability of commercially supported products is achieved, whichever is sooner.
The primary objective of all programs is to accelerate market development. CENSA
takes the program actions its members deem necessary to remove barriers to market
development and to stimulate market growth. The currently active programs are:
1.
2.
3.
4.
5.
6.
7.
Legal and Regulatory Standards
Electronic Recordkeeping and Digital Archiving Systems
Collaborative Electronic Notebook Systems and Applications
Integrated Project Support Environments
Common CENS ArchitectureTM for Integration
Component / Application Integration Tools
Knowledge Management Tools and Systems
CENSA starts a development program by identifying market segments or technical
areas in need of rapid evolution. CENSA then selects existing commercially successful
products or emerging technologies as a technical starting point. We strongly prefer
products targeted at general consumers in broad markets so that economies of scale
will be achieved. CENSA then identifies what selected products do well, and what
features or functions are still missing to meet the more extreme requirements of R&D as
compared to general consumer markets. Finally, CENSA puts collaborative projects in
place to work with the Supplier Members to develop the missing features and functions.
CENSA supplies end user and staff resources on focused teams to assist with many
phases of the product development work. The objective of this work is to lower the cost
• of research and development, as well as the cost of sales for Supplier Members.
A description of each CENSA program and the problems targeted by each one follow.
7.1
Legal and Regulatory Standards for Electronic Recordkeeping and Archiving
CENSA's top priority program, the Legal and Regulatory Standards Program, is focused
on creating the models, policies, and procedural standards necessary for creating and
operating reliable and credible e-records systems. This program is unique because
focuses primarily on creating standards. All other CENSA programs focus primarily on
market development through product creation, enhancement, or deployment activities.
As stated earlier, many technological components are required for complete e-records
technology systems, nearly all of which exist now. However, information technology
changes too quickly and is not reliable per se to construct and operate e-records
systems for long-term preservation and access. It is still a major challenge to know how
to assemble available components into reliable technology solutions. Each technology
is complex and requires more knowledge than the corresponding component in paperbased systems. Beyond that, systems engineering knowledge is required.
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!
,,
-2
A huge problem with information technology at the start of the 21st century today,
whether by design or default, is its rapid obsolescense. Solutions designed using
today's technologies become obsolete quickly, usually within a few years, and almost
always within 25 years. Twenty five years is a short time from legal and historical
perspectives. It is a significant challenge to understand the limitations of today's
information technologies and to compensate for them using documented policies and
procedures. Organizations need to build and operate e-records systems now using
available technologies. The business of government and the government of business
cannot wait for information technologies to mature. With careful design, planning and
operation, today's technologies can be used to build complete technology solutions. We
can compensate for the shortcomings of Information Technology with prudent selection
of manual workaround steps. However, even if perfect "total" technology solutions
existed, reliable operations are needed to have credible records.
To build credible e-records systems, CENSA's Legal and Regulatory Program is
developing specifications and guidelines to help organizations design and operate
"complete" systems as explained earlier. These are developed using the best available
specifications, research results, standards, etc. worldwide as source documents.
CENSA's Legal and Regulatory Program accomplishes its results primarily through the
Global Industry-lnteragency Group on Electronic Recordkeeping and Digital Archiving
Systems (GIIG on ERDAS), which has been funded and hosted primarily by CENSA.
The specific GIIG deliverables are listed below. 2
The GIIG Deliverables- "Good Electronic Recordkeeping Practices"
System Lifecycle Specifications for Electronic Recordkeeping and Digital Archiving
Systems (ERDAS) that clarifies the reference models, policies, process, and procedures
required by an organization to create and preserve electronic records and prove their
authenticity from cradle to grave.
2
Code of Good Practice for (Operating) ERDAS Systems (over the full) Lifecycle
Lifecycle Specifications for Portable Authentic Electronic Records across generations of
technologies
1
4
Validation Guidelines for ERDAS Systems
5 " Indicia of Reliability for Auditing ERDAS Systems that comply with good practices
--.;,
.
Auditing Procedures for Verification of ERDAS System Reliability and Compliance with
Good Practices for ERDAS
Certification Criteria for Digital Records Archives (facilities and archivists)
Training and Education on the GIIG Specifications and other deliverables
CENSA's Legal and Regulatory Program has additional deliverables and projects that
focus on detailed policies and procedures for actually doing system implementations.
2 See www.giig.org or http:llwww.censa.orglGIIGIgiigdeliverables.nsf
for more information.
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Electronic Recordkeeping and Digital Archiving Systems
7.2
In CENSA's Electronic Recordkeeping and Digital Archiving Systems Program, we are
working with Supplier Members to build fully electronic recordkeeping systems.
CENSA's specification work centers around the needs to protect records of creation and
ownership of high-value intellectual property permanently, and to demonstrate
regulatory compliance over periods up to 30 years. CENSA members also must protect
the privacy and confidentiality of personnel records, and protecting against malicious
information warfare. In many respects, industry has the same concerns as the
Department of Defense and many other government agencies.
CENSA's requirements go signficantly beyond the US Department of Defense (DoD)
5015.2 Records Management Application Requirements, and the US Food and Drug
Administration's 21 CFR Part 11 Rule on Electronic Signatures and Electronic Records.
CENSA used these and many other documents as the starting point for specifications.
In March 1998, CENSA released detailed software engineering specifications, called the
CENSA Electronic Recordkeeping Services V10 Functional Requirements
Specification, that articulated requirements of its End User Members.3 The diagram
below shows the major areas covered by the specification.
Desktop
Components
User
I
Authentication
i
Archive
Format
Conversion
I
Common CENS
Framework
Sewer
Components
i
/-
•k•
Time
Certification
ERS Framework
Version 1.0
Server-Side
Components
User
entication
Audit Trailing
Subsystem
Records
Validation
Archiving
Subsystem
Records
Management
Interface
Records
Archive
iiiii
Any Authoring Tool
that can print a
compound document
(e.g., MS-Word, Excel,
LIMS report, etc.)
Auditor's
Interface
ii
l iim mm BIB m
I
Im
IIm mm m
Bim
Migration =1I...
Subsystem
I
BB BB BB BB BB ma ma BB d
i
I Generation I
I Rec°rdsl
LArchive~
i
The ERS Components of the Common CENS Architecture TM Model
3 The CENSA Electronic Recordkeeping Services V1.0 Functional Requirements Specification, released
on a Request For Proposal process run by CENSA from March through June 1998.
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The significance of CENSA's ERS Vl.0 Specification is that this is first time that many
end user industries have jointly given collaborated to produce ERS functional
specifications and run a request for proposal process with vendors. The V I.0
Functional Requirements Specification specifies all major functionality for electronic
recordkeeping and archiving services, e.g., indexing, scheduling, storage, retrieval, and
many other features, with the exception of the migration subsystem. The roles
supported in the V1.0 specification include end users who commit records, records
managers and archivists with responsibility for scheduling and managing records in
archives, system administrators who must set up and operate systems for corporations,
plus reviewers, auditors, patent attorneys, and other users of the system. Migration
subsystem requirements targeted for V2.0 specifications are being developed now.
Several vendors have responded to the CENSA specifications with products already.
Among these are Adobe Systems, Documentum, DOXlS, IceBreaker Communications,
PSSoftware, and others. In 2000 CENSA will start a certification program used to
measure the quality of product implementations of the ERS Functional Requirements.
7.3
Collaborative Electronic Notebook Systems and Applications Program
An Electronic Notebook System is a specialized system for capturing data, authoring
and publishing technical documents, and creating records. It captures data from
desktop and back-end data sources, and connects to back-end data management,
recordkeeping and archiving systems.
Purpose
protocol & Method
Summary
i
Weights II Test
-.:,.
Smart
Card
Reader
Team Project
Information
Systems
In more detail, an electronic notebook system includes a data capture and publishing
system for data from 100s of sources. The picture above show only a few data sources,
however, there are literally hundreds or even thousands of data sources used in large
corporations. At a minimum, the electronic notebook application needs connectors to
high priority data sources. It must make it easy for users with relatively little knowledge
of technical publishing to capture data and compose pages easily, and then commit the
results to the recordkeeping system.
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k-
A major benefit of electronic notebooks for end users is to greatly reduce the manual
labor required to compile data into recordbooks. Another major benefit to users and
corporations includes the capability to search and retrieve online data, records, and
results, which helps with sharing of information in notebooks and other knowledge
sources. Having notebook records online helps large corporations to greatly reduce the
repetition of experiments, a major loss of productivity due to paper-based records today.
In the near future, electronic notebooks will make it easy for technical people to publish
data into and pull data from huge heterogeneous R&D object warehouses containing
data, documents, and records. This will allow unprecedented levels of knowledge
mining and intellectual capital utilization throughout R&D.
The primary legal uses of electronic notebooks are to create, secure, and protect
intellectual property, and to demonstrate regulatory compliance. Data and records from
notebooks are routinely fed into regulatory agency submissions and patent applications.
Paper notebooks lock up valuable intellectual property and prevent people from
leveraging their colleagues' work. Having records in electronic form will remove many
bottlenecks due to paper. Electronic notebooks will greatly speed up these and many
other R&D processes to help accelerate new product time to market.
7.3.1 The CENS Applications Specifications Work of CENSA
In late 1998, CENSA started articulating detailed requirements and functional
specifications for Collaborative Electronic Notebook Systems (CENS) tools. These
tools will be full-blown systems, applications, as well as components that plug into
notebook applications. The Personal Electronic Notebook System (PENS) is a personal
authoring, publishing, data management, and recordkeeping tool focused on individual
end users. A CENS is the collaborative version of a PENS; it provides communication
and connectivity to other system users. CENSA is finalizing its CENS specifications
now. Some of these specifications will be released to the market in late 1999. CENSA
started pilot projects in 1999 with early CENS products. Pilots projects will continue
with these and new products as they are available. CENSA collaborates with its
Supplier Members to help ensure that the pilot projects are successful and are used as
production systems. It also hosts collaborations with Supplier Members to enhance
products to ensure they evolve with the needs of End User Members.
7.3.2 Electronic Notebooks Are Driving Technology Convergence
Near-future electronic notebooks will take advantage of many new technologies all in
integrated, easy-to-use hardware and software packages. For instance, wireless
handheld and pen computers with built-in cameras and microphone will make it possible
to capture high-speed voice, video, and data streams. Pen input with handwriting
recognition software will perform full-speed handwriting to text conversion. Flawless
speech to text conversion engines will make it possible to transform speech into
searchable text "on-the-fly." Infrared or RF data interfaces will make it possible to
transfer data to and from instruments and other lab devices at the touch of a button.
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Intelligent Agents and software assistants will perform information collection and
processing functions, returning initial results of research automatically after being given
a series of research directives by the user. "Ubiquitous recordkeeping" will make it
possible to use an electronic notebook software and hardware system anywhere to
capture and author data and subsequently commit records to back-end archiving
systems. Ultimately, technology convergence will make electronic notebook systems
interoperable with cell phones, computers, the World Wide Web, VCRs, electronic
books, digital libraries, data management, and recordkeeping systems.
CENSA End User Members are performing evalutions and pilot projects of leading-edge
technologies and products now and feeding the results back to the association for
sharing with other End User Members. This evalution knowledge helps member
companies stay on the leading edge of technology without expending the additional
effort themselves to evaluate new techologies and products themselves. It also feeds
into CENSA specifications for prototypes and new products from Supplier Members.
7.4 Integrated Project Support Environments (IPSE) Program
,.
An Integrated Project Support Environment (IPSE) is a "super-notebook" or application
environment that includes a CENS application. The electronic notebook is only one tool
that is used by scientists, engineers, and other authors in the course of their work.
Many other desktop software applications, databases, and data sources are used. An
IPSE is a software framework that makes it easy to use all of these tools in consistent
and easy ways. CENSA feels that it is necessary to go beyond notebook and
recordkeeping applications to solve the problems of integrating data and applications
with significantly more powerful environments that facilitate knowledge work. The
targeted timeframe for IPSE products that include notebook applications is mid-2000.
7.5
.,
.
"
..
Common CENS Architecture TMProgram for Systems Integration
A component-based architecture is a design for modular systems that allows someone
with little skill or specialized expertise to assemble complete systems from simpler parts
purchased from multiple vendors, similar to consumer stereo HiFi components or the
musical instruments device interface (MIDI). In the case of advanced R&D automation
systems, we require more component standardization just analog or even digital signal
interfaces. However, the concept is the same for R&D automation software making
connections among electronic notebooks and other advanced automation tools.
The Common CENS ArchitectureTM Program for Systems Integration is important to
industry because it allows DeoDle without computer language programming skills to
assemble working systems from components sold by different software manufacturers.
We emphasize people without programming skills because it makes the point that
integration must be very easy or we simply will not have the manpower to do the work
needed in the near future. The cost of constructing systems that are integrated with
other business systems is reaching 80% of the total cost of a system. The cost of
software and hardware is decreasing to less than 10% of the total system cost. Clearly
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some major innovations must happen to address this problem, especially considering
that many businesses are striving for 100% automation of information management,
fighting against the increasing shortage of trained IT professionals moving into the next
millenium. CENSA has started to collect the requirements and specify the reference
architecture with well-defined concepts and interfaces that will make this possible.
7.6
Component and Application Integration Tools Program
As stated earlier, the major constraint of automation today is integration of data and
applications. We need ways to make end users and integrators many times more
productive than today. To make component-based integration not only possible, but
easy, CENSA is driving the creation of extremely powerful tools that help analysts and
end users do systems integration themselves using "programmerless" integration and
configuration tools. CENSA is researching their business and technical requirements
now. We are collecting extensive information on available products, and starting pilot
projects with selected products, to identify how well they work and what's still missing.
The overall program objective is to make the new integration tools fit R&D automation
needs much better than today. The results will apply to many other markets.
7. 7 Knowledge Management Tools and Systems Program
Better knowledge management (KM) is a key reason for making notebooks and other
research records electronic. KM is nothing new to R&D knowledge workers. Scientists
and engineers are trained in the Scientific Method and to use recordbooks for capturing
knowledge as it is being created. Scientists and engineers know how to do knowledge
capture very well, because they are taught about keeping notebooks from their very first
science class. The notebook is kept in order to document initial concepts, the
processes and procedures used to verify the validity of a new idea, the results from
developing the idea, and the conclusions stating whether it worked and why it is
significant. In fact, recording knowledge for future reference is a primary task of R&D
knowledge workers. Librarians, information scientists, and records managers are
professional knowledge managers, charged with instituting programs for managing
formalized knowledge. To scientists, engineers, librarians, and records managers,
"Knowledge Management"is a patent restatement of the obvious. Sometimes scientists
or engineers may forget their rigorous training, but in general KM, in its simplest form, is
merely the application of these good laboratory practices to other disciplines. 4
An objective of CENSA's work is to better utilize intellectual capital generated during
R&D processes. CENSA's first programs have focused on securing information in
electronic form for as long as needed by the business and for historical reasons. By
adding PENS, CENS, and IPSE applications connecting electronic records repositories,
databases, digital libraries, and data warehouses, these advanced tools will permit an
unprecedented level of knowledge capture, management, and utilization.
4 James T. Currie, Jr., "Don't Reinvent the Wheel, Pathways to Knowledge Management," a lecture from
the CENSA training course on "Collaborative Electronic Notebooks and Knowledge Management
Systems for R&D Enterprises." See www.censa.org for more information.
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i:i
.•r
r,
Reuse of intellectual capital is a fundamental problem with paper-based information.
Some corporations are simply scanning notebooks and indexing the scanned images
with keywords. This is clearly inadequate when compared with documents created in
electronic form. However, some records never existed in electronic form, so no other
options exist; these include audio, video, and other data dynamically varying types.
Good KM programs must address the indexing and retrieval of this information.
CENSA has been working to fix the basic basic problems with IT per se that prevent it
from being used for long-term preservation and access of electronic records. In 2000,
CENSA will focus more on developing better automated tools for knowledge
management in R&D. CENSA's KM tools research began in 1999 and will continue
through 2000. Members are supplying experts with corporate KM responsibilities to
assist with this development work. This research will feed advanced specifications,
which will be turned into advanced products by CENSA Supplier Members.
8 Summary and Conclusions
CENSA is a unique industry association comprising end users, suppliers, government
agencies, and academic institutions. CENSA's mission and processes are unique
because of our focus on developing new and emerging markets by providing research
and engineering resources and whatever else is necessary to remove barriers to
thriving markets. CENSA's focuses on the global problems of intellectual property
protection, compliance with government regulations, and evolving R&D automation
markets, infrastructure, and tools.
CENSA has a very strong focus on electronic recordkeeping and digital archiving
systems now, because this is fundamental to replacing paper-based recordkeeping with
electronic systems. This paper discussed the required components of a "complete
system" for electronic recordkeeping, and what CENSA is doing to make such systems
easy to implement. CENSA's program for creating CENS Applications is aimed at
making data compilation and recordkeeping easy to increase the productivi~,of the
individuals and teams. The composed-based Common CENS Architecture'"' for
integration and its component integration tools will make it possible to slash the cost
and time required to construct powerful R&D automation systems. The inability to do
rapid data and application integration is a major constraint in all automation now.
Integration problems are only accelerating as organizations become more dependent on
computers. CENSA is specifying powerful "programmerless" integration tools that will
be applicable to many markets outside of R&D. Better knowledge management and
intellectual capital utilization is an implicit objective of CENSA's programs. CENSA is
focused at the market development level and helping to drive convergence of many
technologies that will make better Knowledge Management simply a by-product of
applying more powerful R&D automation tools. CENSA is helping to drive these and
other changes in market dynamics in order to accelerate progress in R&D automation
systems. See www.censa.org for more information.
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Copyright © 2000 - CENSA, The Collaborative Electronic Notebook Systems Association
800 West Cummings Park, Suite 5400, Woburn, Massachusetts 01801 U S A - Web: www.censa.org
14 Background on CENSA
<
CENSA, the Collaborative Electronic Notebook Systems Association, is a market development
association focused on catalyzing markets for advanced automation for research and development
organizations. CENSA uses unique market development programs that involve end users, suppliers,
and government agencies working together to identify, specify and create solutions to market
problems faster than normal methods. With over 800,000 employees in CENSA member
organizations, CENSA has a broad impact across many sectors, including software, high-tech,
consumer products, chemical, pharmaceutical, biotech, healthcare, government and many others.
CENSA emphasizes regulated industries where intellectual property protection is key to success.
i
• ,
.
CENSA's current market development programs focus on systems for long-term preservation and
access of electronic data and records, electronic notebook authoring applications, architectures and
tools for component-based application and systems integration, and high-priority scientific,
technical, and business components. CENSA's deliverables to its members are specifications for
complete systems, component software and hardware technologies and products, and extensive
specialized knowledge for setting up and using the systems and tools successfully.
CENSA sponsors the Global Industry Interagency Group on Electronic Recordkeeping and Digital
Archiving Systems (GIIG on ERDAS), a non-profit organization of government agencies and
industries dedicated to defining and implementing acceptable systems for long-term preservation
and access of electronic data and records in industry and government applications.
,
.
'i
i
i¸
i
15 Background on the Authors
Rich Lysakowski, Executive Director, CENSA
Rich Lysakowski is the Executive Director of the Collaborative Electronic Notebook Systems
Association (CENSA). He has 20 years experience in various scientific, engineering, marketing,
and project management roles in the private and public sectors. He has a Ph.D. in Physical and
Analytical Chemistry, with a specialization in R&D and laboratory automation. He has done over
one hundred presentations at conferences and workshops, authored over 30 publications, and edited
two books. He also teaches regularly for the American Chemical Society and other professional
organizations. He holds two patents on software technologies.
Zahava Leibowitz, M.A., ABD, Researcher and Writer, CENSA
Zahava Leibowitz is a researcher and writer for CENSA. She specializes in medical and technical
writing, technology research, regulatory compliance and validation issues and documentation,
document management systems, and project management. She has numerous publications to her
name, and has been the senior editor for two books. She has over ten years experience in teaching
writing and editorial strategies.
16 For More Information
.,:
For more information on CENSA and solutions to these problems, please contact:
CENSA, 800 West Cummings Park, Suite 5400, Woburn, MA 01801 USA
Phone" 781-935-9600; fax" 781-935-3113; E-mail: [email protected]; website: ~ , c e n s a . o r g .
173
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