The MIDI Sherlock® Microbial Identification System
Rapid Microbiology for the 21st Century
Overview
Proven Accuracy
For over 15 years, clinical and environmental customers
have relied on the automated Sherlock® Microbial
Identification System as a rapid solution for the
identification of bacteria and yeast. The Sherlock System
represents a rapid, accurate and comprehensive solution
for the identification of over 1,500 microbial species,
including the 6 major bacterial agents of bioterrorism
classified by the U.S. Centers for Disease Control (CDC).
What makes the Sherlock System unique is that all
microbes are analyzed using the same procedure with no
offline tests, gram stains or biochemical cards required.
The Sherlock System is an established microbial
identification technology with proven accuracy over a wide
range of microbes. The Sherlock System has over 600
peer-reviewed journal articles to its credit and is a CDC
Official Method for identification of aerobic bacteria. For
confirmation of Bacillus anthracis (the anthrax pathogen),
the Sherlock System has 2 distinctions: it is the only system
that is cleared by both the U.S. Department of Homeland
Security and U.S. FDA for B. anthracis confirmation.
Technology
Key Benefits of the Sherlock System
POLYPHASIC
More than 300 fatty acids and related compounds have
been found in the microbial cell membrane. The Sherlock
System identifies microbes based on gas chromatographic
(GC) analysis of extracted microbial fatty acid methyl esters
(FAMEs). Microbial fatty acid profiles (fingerprints) are very
unique from one species to another, and this fact has
enabled MIDI to create large microbial libraries, as well as
tools for tracking samples against tens of thousands of
previous runs. Sophisticated pattern recognition algorithms
are used to match the unknown microbial FAME
fingerprints to the Sherlock libraries. Sherlock software
automates all analytical operations.
Identification by FAME and DNA technologies.
RAPID
FAME extract to identification in under 10 minutes.
AUTOMATED
Easy-to-use with no GC experience required.
COMPREHENSIVE
FAME and DNA libraries contain over
2,500 microbial species.
New in 2006- Sherlock System adds
DNA Sequencing Capabilities
STANDARDIZED
Beginning in 2006, MIDI has incorporated DNA Sequence
analysis into the Sherlock System. As a result, Sherlock
users will be able to increase the number of microbial
species they can identify from 1,500 (current FAME
system) to over 2,500 microbial species by a combination
of 16S (bacteria) and 28S (fungi/yeast) rRNA sequence
analysis, in addition to the standard FAME approach. The
addition of DNA Sequencing will allow Sherlock users to
create combined phenotypic (FAME) – genotypic (DNA
Sequencing) reports, the first of any automated microbial
identification system on the market. The addition of DNA
Sequencing technology to the Sherlock platform
represents MIDI’s continued pursuit to develop the
most accurate and advanced microbial identification
system in the industry.
INEXPENSIVE
MIDI Inc.
800-276-8068
125 Sandy Drive
Sample preparation is the same for all microbes.
Low-cost consumables with no biochemical cards.
PRODUCTIVE
Strain tracking, data export and analysis tools.
SAFETY
Microbe is killed during the first preparation step.
COMPLIANCE
Timesaving validation package and
Support for 21CFR Part 11.
Newark, DE 19713 USA
[email protected]
Sherlock£ 6.0 Microbial Identification System
Specification Sheet
General Description
®
The Sherlock Microbial Identification
System identifies bacteria and yeast by gas
chromatographic (GC) analysis of fatty acid
methyl esters (GC-FAME). The Sherlock
software, methods and libraries are
combined with an Agilent® Technologies
6890 or 6850 GC and Agilent ChemStation
software for a complete automated microbial
identification solution.
Sherlock’s pattern recognition algorithms,
combined with its calibration mixture,
standardize each instrument. This virtually
eliminates the manual calibration
adjustments associated with
a GC. No chromatography knowledge or
experience is required.
Microbe Libraries
Sherlock methods and libraries are available
for the following applications.
Environmental Aerobes
The environmental library contains 695
species. The standard culturing media
used is TSBA. The standard incubation is
28o C for 24 hours.
Clinical Aerobes
The clinical library contains 430 species.
Blood agar is the standard culturing
media. The standard incubation is 35o C
for 24 hours.
Anaerobes
Two anaerobe libraries are available. One
is for BHIBLA plate-grown anaerobes
(135 species). The other is for PYG
broth-grown anaerobes (590 species).
Yeast
The yeast library has entries for 190
species grown at 28o C on Sabouraud
Dextrose Agar for 24 hours.
Bioterrorism/Biowarfare
This library identifies 6 major bacterial
agents of bioterrorism/ biowarfare, plus
30 closely related species. Combined
with the Clinical Aerobe library, the
Bioterrorism library is a powerful tool for
confirming bacterial threat agents
(Developed with the U.S. Army Medical
Research Institute for Infectious Diseases,
USAMRIID, Fort Detrick, MD).
Low Costs Per Sample
Sample Preparation
It costs under $3.00 USD per sample
for all consumables. This includes
reagents, gases, calibration standards,
glassware, and culture media.
Using inexpensive reagents, available
from almost any chemical supply
house, a technician averages only 5
minutes per sample to prepare a batch
of 30 samples. Each sample is
prepared for analysis using a liquidliquid extraction in a single test tube.
x Harvesting a small quantity of cells
from the culture plate is the most
labor-intensive step. It will typically
take 1 hour or less to harvest cells
from 30 plates into 30 test tubes.
x The four-step liquid-liquid
extraction process requires about 1½
hours or less for a batch of 30
samples. During the extraction
process, approximately 35 minutes
of “wait time” are available for the
technician to do paper work and
other tasks.
x The same sample preparation is used
on all samples. It is not necessary to
do a Gram stain or other offline tests
before preparing and analyzing a
sample.
Instrument Throughput
Following a short preparation
procedure (typically done in batches),
the sample vials are loaded into the
instrument’s autosampler. The
automated system takes over and
quickly analyzes each sample. No
additional incubation is needed at this
point.
x Standard methods process 2
samples per hour on single channel
instruments and 4 samples per hour
on dual channel instruments.
x Rapid methods for Environmental
Aerobes, Clinical Aerobes and
Bioterrorism bacteria process
6 samples per hour on a single
channel and 12 samples per hour on
a dual channel instrument. This
method has 2 times the detection
sensitivity of the Standard methods.
x Sensitive methods for Anaerobes
and Yeasts process 2 samples on a
single channel and 4 samples on a
dual channel instrument per hour.
This method has 2 times the
detection sensitivity of the Standard
methods, and uses the same
calibration standard as Rapid
methods.
Culturing
Like all widely used confirmatory
techniques, Sherlock requires pure
microbial cultures. Using standard
laboratory techniques, a primary
isolation plate is incubated for 24 hours
for a typical sample. If the primary
plate appears to be a single organism, a
small cross-section of cells is harvested
and incubated for 24 hours on a
secondary plate. If the primary plate
appears to be a mixed culture, a colony
or each type may be subcultured. Slow
growing organisms will require longer
incubation times.
MIDI, Inc.
Newark, Delaware
Bio-Safety
Bio-Safety is enhanced because live
organisms are not introduced into the
instrument. The first step of the
extraction procedure treats the cells
with a sodium hydroxide solution for
30 minutes in a 100o C water bath.
After the first step, the technician is no
longer working with live organisms.
Laboratories that handle dangerous
pathogens will typically perform the
sample extraction in a BSL-3 lab and
transfer decontaminated extracts to a
non BSL-3 lab for instrument analysis.
This allows the instrument to be
maintained and serviced by technicians
outside the BSL-3 lab.
Instrumentation
Strain Tracking
Sherlock DNA
A Sherlock system is composed of a
Windows® XP or 2000 based computer
loaded with the MIDI Sherlock software
and an Agilent ChemStation. The
computer is interfaced to one of the
following instruments:
x Agilent 6850 GC with single column
and a 27-vial autosampler.
x Agilent 6890 GC with a single
column and a 100-vial autosampler.
x Agilent 6890 GC with dual columns
and a 100-vial autosampler.
Tracker/Cluster is an optional strain
tracking package. It is a powerful tool
that helps locate the source of a
contamination.
Tracker locates other samples that are
likely to be the same strain as a sample
of interest. Tracker searches for strain
matches between the current sample and
all previous samples. Uses include:
x Trend analysis
x Summary reports for sample sets
x Microbe population studies
x Research and publications
x Data mining
Cluster, is a new module that
automatically finds groups (clusters) of
highly related samples. Relationships
between clusters and samples can be
explored using:
x Dendrogram plots
x Neighbor-joining trees
x 2-D Color-coded PCA plots
Tracker and Cluster operate
independently of sample identification,
allowing unknown samples to be
compared.
Sherlock DNA is an optional package, which
allows for identification and analysis of
microbial DNA sequences. Sherlock DNA
comes with 16S rRNA gene sequence
libraries for bacterial identification and an
optional 28S rRNA add-on for fungi/yeast
identification. The system is not limited to a
specific DNA product. Custom libraries
can be created from your samples.
Analysis
Relationships between samples can be
explored using:
x Dendrogram plots
x Neighbor-joining trees
x Principal component analysis (PCA)
with 2-D plots and histograms
The graphics can be exported to
Microsoft Office® and other packages
for further analysis and for research
publications.
Custom Libraries
Using the optional Library Generation
System (LGS), custom libraries can be
created from your samples. Uses for
custom libraries:
x Quality control of proprietary strains
used in production processes
x Quickly recognize contaminants that
reoccur in a facility or process
x Assign an identity to organisms that
do not have a published taxonomy
x Catalog culture collections
x Research
Data Export
Data Export software exports sample
data, fatty acid profiles, library match
results, and other information to Excel®
spreadsheets and Access® databases.
There are many applications for custom
reports and calculations created using
Excel, Access, and other data analysis
tools:
x Trend analysis
x Custom reports
x Summary reports for sample sets
x Microbe population studies
x Research and publications
x Data mining
21 CFR Part 11
The optional Electronic Records and
Signatures (ERS) package can be added
to support compliance with FDA
regulation 21 CFR Part 11.
x Provides access control based on
Windows XP or Windows 2000 user
passwords and group settings to
authenticate users and determine their
privileges.
x When configured with a Windows XP
or Windows 2000 domain, users can
be authenticated using their domain
credentials.
x Sherlock requires the user to logon
before granting access to controls and
data.
x Packages all associated data, audit
trails, logs and results in a secure
electronic vault for storage on the
local disk or on a remote file server.
x Supports two levels of electronic
signature authority with notes added
by the signer.
x Automatic inactivity logoffs.
x Supports security policies defined for
the Windows XP/2000 system or
domain, including lockout of accounts
after a predetermined number of login
failures.
In addition Sherlock DNA makes it possible
to have a combined fatty acid- DNA
sequence report for a polyphasic approach
to identification.
Markets Using Sherlock
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Animal Science
Bioremediation
Biodefense / Bioterrorism
Clinical Diagnosis
Dental Research
Entomology
Epidemiology
Food Microbiology
Marine Science
Medical Research
Pharmaceutical QC
Plant Pathology
Soil Science
Water Quality
Taxonomy Studies
www.midi-inc.com
The information in this publication is
subject to change without notice.
MIDI & MIDI Authorized distributors
are the sole source for the Sherlock
Microbial Identification System.
Copyright ¤ 2005 MIDI, Inc.
All Rights Reserved
Date: 20 December 2005
MIDI, Inc.
125 Sandy Drive
Newark, Delaware 19713
Phone: 302-737-4297
Fax: 302-737-7781
Email: [email protected]
Sherlock® Microbial Identification System (MIS)
Major Bacterial Species the MIDI System Identifies
Environmental and Clinical Markets
GRAM(+) Cocci
Fastidious Gram(-) Rods
Micrococcus spp.
Staphylococcus spp. (clinical only)
Streptococcus spp.
Actinobacillus spp.
Bartonella spp.
Brucella spp.
Capnocytophaga spp.
Cardiobacterium spp.
Chromobacterium spp.
Eikenella spp.
Francisella spp.
Kingella spp.
Legionella spp.
Streptobacillus spp.
Suttonella spp.
Yersinia spp.
GRAM(+) Rods
Bacillus spp.
Gordonia spp.
Nocardia spp.
Rhodococcus spp.
Streptomyces (genus only)
Other Actinomycetes
Nonfermentative Gram(-) Rods
Anaerobic Bacteria
Achromobacter spp.
Acinetobacter spp.
Alcaligenes spp.
Brevundimonas spp.
Burkholderia spp.
Comamonas spp.
Methylobacterium (genus only)
Moraxella spp.
Pseudomonas spp.
Ralstonia spp.
Stenotrophomonas spp.
Other Nonfermentative Gram(-) Rods
Gram(+) and Gram(-) anaerobes
Biothreat Agents
Bacillus anthracis (Anthrax)
Brucella melitensis (Brucellosis)
Burkholderia mallei (Glanders)
Burkholderia pseudomallei (Melioidosis)
Francisella tularensis (Tularemia)
Yersinia pestis (Plague)
Sherlock£ Rapid Methods
The Same Results 3x Faster
Fact Sheet
General Description
2
System Requirements
The rapid methods will not work with the
5890 GC or older versions of Sherlock.
The following are required:
x Agilent 6890 or 6850 GC
x Sherlock version 4.5 or higher
4
8
10
13.571
10.784
10.936
9.724
9.116
6
12
14
16
m
Matches:
Library
TSBA50 5.00
Sim Index
0.938
0.577
Entry Name
Bacillus-subtilis
Bacillus-atrophaeus
Figure 1- Standard Method for a B. subtilis sample
16
3.0033.034
2.373
2.402
0.723
*FID1 A, (A0042025.D)
pA
14
12
8
6
4
0.5
1
1.5
2
2.5
3
3.433
2.617
2.686
2.734
2.802
2.933
2.963
10
2.072
2.180
Figure 1 shows the chromatogram and
Sherlock library search results for a
Bacillus subtilis analyzed with the
standard chromatographic method.
Identical results are obtained much faster
using the rapid method (figure 2). The
two chromatograms are nearly identical
except for the different time scales. The
peak that elutes at 13.571 minutes using
the standard method elutes at 3.433
minutes using the rapid method. The
analytical run is 3.9 times faster. The
total throughput, which includes the time
for the GC to prepare for the next run, is
approximately 3 times faster.
4.163
4
6.470
6.976
9.509
5
10.121
6
Rapid Chromatography
The rapid methods take advantage of the
advanced electronic flow control features
of the Agilent£ 6890 and 6850 gas
chromatographs to obtain the same
results using the same GC column in a
fraction of the time.
11.196
11.356
7.916
8.052
7
1.179
x Same day identification of isolates
x Samples requiring reanalysis can
be processed immediately
x Fewer cells used for analysis
reduces culturing time for slow
growing organisms
x Easier harvesting of cells for
analysis reduces labor
x Reduced injection port maintenance
due to less material being injected
x Improved results for organisms
containing mycolic acids
8
2.886
Advantages
FID1 A, (A0132085.D)
pA
1.562
Rapid methods with corresponding
libraries (databases) get the same
results three times faster than their
standard method counterparts. Rapid
methods are 2.5 times more sensitive,
reducing the number of cells needed for
the analysis.
3.5
Matches:
Library
RTSB50 5.00
Sim Index
0.938
0.582
Entry Name
Bacillus-subtilis
Bacillus-atrophaeus
Figure 2- Rapid Method for the Same B. subtilis
4
m
Rapid Libraries
Operation
Available Methods
When the same sample is analyzed
with both the Rapid and Standard
methods, the match results for the
Rapid library are nearly identical to
those for the Standard library. The
Rapid libraries were generated from
the same data as the Standard
libraries.
x Harvest only ca. 20mg wet weight
of cells (2 to 2.5 times less than
the 40 to 50mg for the standard
method). Fewer cells should be
used to avoid overloading the
more sensitive GC analysis.
Rapid methods are currently
available for the following
applications:
The Rapid methods and libraries
improve results for organisms,
containing mycolic acids. Cleavage
of mycolic acid side chains may
result in fragments being randomly
named as fatty acids by the Standard
methods. Chromatography
improvements let the Rapid method
and library mostly ignore these
fragments.
x The remainder of the sample
preparation procedure is identical
to the standard method. The
same reagent volumes, reaction
temperatures, and times are used.
Calibration Standard
x Enter the calibration mix and
samples into the Sherlock
Sequencer’s sample table. Select
the appropriate Rapid Method
(RTSB50, RCLN50, or RBTR50)
rather than one of the standard
methods.
With the increased sensitivity, the
Rapid methods require a new
calibration standard. The Rapid
Method Calibration Mix (MIDI part
no. 1300-A) is packaged in
distinctive brown glass ampoules.
x Samples using standard methods
(e.g. the Moore anaerobe
method), with their calibration
standards, can be entered in the
same sequence.
Compatibility
The Rapid methods use the same
analytical column as the standard
methods. This allows one instrument
to run both Rapid and standard
methods.
x The analytical speed allows time
during the workday for operators
to review results and reanalyze
samples that require dilution or
concentration.
x Environmental Aerobes
The environmental library contains
690+ species. The standard
culturing media used is TSBA.
The standard incubation is 28o C
for 24 hours.
x Clinical Aerobes
The clinical library contains 410+
species. Blood agar is the
standard culturing media. The
standard incubation is 35o C for 24
hours.
x Bioterrorism
This library identifies the 6 major
bacterial agents of bioterrorism
plus another 15 closely related
organisms. Combined with the
Clinical Aerobe library, the
Bioterrorism library is a powerful
tool for confirming a biological
attack. (Developed with the U.S.
Army Medical Research Institute
of Infectious Diseases, Fort
Detrick, MD, the Bioterrorism
library is available free of charge
to qualified owners of a MIDI
Sherlock system.)
Standard method samples can be
mixed, in the same sequence, with
Rapid method samples. The
electronic pressure and flow control
of the 6890 and 6850 allow Sherlock
to establish the correct operating
conditions for each method.
Validation
MIDI followed in-house procedures
to validate the Rapid methods and
libraries. The Rapid methods and
libraries ship with a certificate of
validation. Validation documents are
available for inspection at MIDI’s
office in Newark, Delaware.
www.midi-inc.com
The information in this
publication is subject to
change without notice.
Copyright ¤ 2002 MIDI, Inc.
All Rights Reserved
Date: 31 October 2002
MIDI, Inc.
Newark, Delaware
MIDI, Inc.
125 Sandy Drive
Newark, Delaware 19713
Phone: 302-737-4297
Fax: 302-737-7781
Email: [email protected]
Sherlock® Tracker/Cluster
Strain Epidemiology With Real-Time Results
MIDI, Inc
125 Sandy Drive
Newark DE 19713
(302) 737-4297
[email protected]
Scan thousands of
samples automatically
for closest matches
Track strains quickly
and easily-even
unknowns
Create your own data
sets to track against
No prior knowledge of
the sample is required
Tracker Fact Sheet
Where and When have
I seen this bacteria before?
Description
MIDI Inc.’s Sherlock® Microbial Identification System (MIS) has provided
strain tracking as a manual capability of Sherlock’s advanced Library
Generation Software (See Technical Note #102). Sherlock Tracker is an
add-on module for the Sherlock 4.5 and 6.0 versions that enhances
Sherlock’s strain-tracking ability.
Tracker automatically compares the cellular fatty acid profile of a sample to a
database of previously analyzed samples. A report is generated of the
samples that are most similar. Tracker can track samples, whether or not
the samples match known bacterial species in MIDI’s extensive libraries.
Comparisons can also be made automatically after each sample run, so that
you will know immediately if you have seen the sample before.
Database Creation
With a few mouse clicks, the user can build a Tracker database. Data from
Sherlock samples, even samples run on previous versions of Sherlock, may
be quickly combined to create a Tracker database for searching. New
samples may be automatically added to the database as Sherlock runs them.
Track samples
automatically after each Online Tracker Reports
run or in offline mode Tracker may be configured to automatically generate reports as each
Sherlock sample completes.
Offline Investigation with Tracker
Detect contaminants
Using the Tracker mode in Sherlock’s CommandCenter, samples may be
and identify nosocomial evaluated against Tracker databases, and new reports generated.
outbreaks faster
Tracker Example
In Figure 1, Tracker was
used “in house” to compare
the strain of anthrax found
in Connecticut to MIDI’s
BIOTER1.0 library anthrax
entries. The strain matched
with the Ames strain at a
Cutoff Factor of 3.000,
indicating the same strain.
Inquiry
Match
Figure 1- Tracking Anthrax in the Connecticut Case- Data courtesy
of the Connecticut Department of Public Health Laboratory
Sherlock® Tracker/Cluster
Strain Epidemiology With Real-Time Results
MIDI, Inc
125 Sandy Drive
Newark DE 19713
(302) 737-4297
[email protected]
Cluster Fact Sheet
Introducing Cluster
Description
Cluster is a new analytical
tool available in Sherlock 6.0
with the Tracker option.
Cluster automatically creates
groups of similar samples.
Two separate clustering
algorithms are used allowing
the user to easily create
clusters and determine the
relationship between these
clusters.
Uses
Quality Control trending and
tracking.
In some cases a particular type of
bacteria is seen consistently within a
pharmaceutical process. Clustering
allows identification of samples that fall
into the group; Samples that fail to
match the group may indicate a change
in the pharmaceutical process.
Figure 2 - Cluster Detail View
Identification of new bacterial
species.
A cluster of closely related samples may
indicate the existence of a new species.
These samples can form the backbone
for delineating the new species.
Location of unexpected patterns in
data.
A cluster may contain a wholly
unanticipated connection among
samples, such as day of week, time of
year, or processing technician. Once
the cluster has been defined, the
analyst can evaluate the associated
samples to identify such patterns.
Figure 3 - Principle Component Plot of Largest Clusters
Sherlock® Data Export
Advanced Sherlock Data Management
Fact Sheet
How do I create a customized report
from my Sherlock identification data?
Export Sherlock data to
spreadsheets and
databases with ease
Description
Sherlock Data Export is an optional extension to MIDI Inc.’s Sherlock®
Microbial Identification System (MIS). Data Export can be used to export
Sherlock information to a database or a spreadsheet. Once the information is
exported to these industry-standard files, an array of analysis, reporting and
charting tools may be used.
Generate custom
reports for your facility
or project
Data Export creates Microsoft Access® databases and Excel® spreadsheets.
Microsoft Office® is not required to use Data Export- many packages accept
databases and spreadsheets in these formats- however, to get the full value
from Data Export, Microsoft Office is suggested.
Customized Reports
Automatically gather
and monitor calibration
performance
Data Export allows the Sherlock user to make customized reports, especially
with the use of Excel and Access programs. Examples of customized reports
(Figures 1-4) include: Calibration performance, hydroxyl fatty acid recoveries,
best match reports and Similarity Index (SI) plots.
Export 2-D plots to
spreadsheets for
publication purposes
Figure 1- Sherlock Calibration Performance- this report gives a summary of calibration
performance for each sequence run. Changes to the query and report could be made
to report, for example, weekly calibrations instead of all sequences, or to include more
or less information.
Automatically monitor
injection port liner and
column performance to
minimize downtime
Hydroxyl Percentages
2.3
10:0 2OH
16:0 2OH
Low Percent
2.1
2
Date
9/11/01
8/28/01
8/14/01
7/31/01
7/17/01
7/3/01
6/19/01
1.9
6/5/01
Percent
2.2
Figure 2- Hydroxyl Fatty Acid Recoveries- the
following chart shows percentages of 10:0 2OH
and 16:0 2OH in calibration runs over time. In this
case, the hydroxyl percentages stay above the
cutoff of 2%. This type of report can be used to
monitor injection port liner and column
performance.
Figure 3- Result Summaries- with Data Export, a report can be created that has one line per sample with
specific information selected for that sample, such as the the “best match.”
Date
ID_Nbr Samp_Id
%Named Sim_Index Name
9/26/2001
10762 UN-MIDI-B-1(4343-01177
100.00
0.853 Bacillus-megaterium-GC subgroup
9/26/2001
10763 UN-MIDI-B-1(4345-01177
100.00
0.703 Micrococcus-luteus-GC subgroup
9/26/2001
10764 UN-MIDI-B-1(4349-01178
93.64
9/26/2001
10765 UN-MIDI-B-1(4357-01179
100.00
0.842 Bacillus-cereus-GC subgroup A*
9/26/2001
8627 UN-MIDI-A(2203-15604B
100.00
0.676 Acinetobacter-radioresistens
9/26/2001
8628 UN-MIDI-A(2204-15605
100.00
0.768 Acinetobacter-baumannii
9/26/2001
8629 UN-MIDI-A(2205-15619A
100.00
0.575 Acinetobacter-radioresistens
9/26/2001
8630 UN-MIDI-A(2206-15623A
99.08
0.924 Stenotrophomonas-maltophilia*
9/26/2001
8631 UN-MIDI-A(2207-15624F
99.43
0.756 Stenotrophomonas-maltophilia*
9/26/2001
8633 UN-MIDI-A(2209-15647
100.00
0.617 Brevibacterium-linens*
0.443 Paenibacillus-gordonae*
Figure 4- Summary Statistics- in this example,
a set of QC samples, all identified correctly as
Stenotrophomonas maltophilia, is exported to
Microsoft Excel using Data Export. The
Similarity Index (SI) over time is plotted to
look for any unusual trends.
www.midi-inc.com
The information in this
publication is subject to
change without notice.
Copyright ¤ 2002 MIDI, Inc.
All Rights Reserved
Date: 03 November 2002
MIDI, Inc.
Newark, Delaware
MIDI, Inc.
125 Sandy Drive
Newark, Delaware 19713
Phone: 302-737-4297
Fax: 302-737-7781
Email: [email protected]
Sherlock® ERS
Electronic Records and Signatures
Fact Sheet
Is your Bacterial Identification
System 21 CFR Part 11 Compliant?
FDA 21 CFR Part 11
compliant software
Data from each batch is
stored in a
single, secure file
User authentication is
required at key
operational points
Description
Sherlock Electronic Records and Signatures (ERS) is an optional extension
to MIDI Inc.’s Sherlock® Microbial Identification System. Sherlock ERS
permits controlled data access to authorized personnel. A core component to
21 CFR Part 11 compliance is the ability to link all related transactions to an
electronic signature and to track any associated changes made to a secure
file. Sherlock ERS preserves the data, methods, libraries and audit trail from
a Sherlock sequence in a single, secure file.
The Sequence Audit Log details all of the actions taken while the sequence
was run, showing the date, the user name and the activity. Changes after
the data have been collected, such as approval or rejection of a sample, are
detailed in the Audit Log, which also displays the date, name and associated
action. The Audit Log shows the old and new values for each change.
Security
Electronically sign each
report and attach
comments
In order to comply with the FDA’s requirement that an electronic signature
must employ at least two distinct identification components, such as a
username and password, Sherlock ERS requires this information at every key
operational point in the system. Sherlock ERS is integrated with the
Windows® NT and 2000 security models. Authorized ERS users and
passwords are determined by the local or network system administrator,
depending on the environment that the Sherlock system is employed in.
Create an audit trail of
all entries and actions
on an ERS file
Regenerate original
reports and view
chromatograms
ERS View
Sherlock ERS permits review and
verification of electronic records
through a Windows®-based
interface. Authorized users are
able to view sample information,
reports, chromatograms and audit
logs. In addition, select changes
can be made to ERS files,
depending on the level of authority
the user has.
Figure 1- Sherlock ERS View
www.midi-inc.com
The information in this publication is
subject to change without notice.
MIDI & MIDI Authorized distributors
are the sole source for the Sherlock
Microbial Identification System.
Copyright ¤ 2005 MIDI, Inc.
All Rights Reserved
Date: 20 December 2005
MIDI, Inc.
125 Sandy Drive
Newark, Delaware 19713
Phone: 302-737-4297
Fax: 302-737-7781
Email: [email protected]