Selecting The Proper LIMS A Systematic Approach To Guarantee A Successful Implementation Robert Walla Astrix Technology Group New York . West Palm Beach . Boston . Philadelphia . Kansas City . Los Angeles 1 www.astrixtechgroup.com NEMC 2011 Why Do We Need A Systematic Approach To Select A LIMS? 2 NEMC 2011 Major Life Purchases Automobile House Usually Purchased Based On High Level Requirements 3 NEMC 2011 LIMS High Level Requirements Must Be User Friendly Must Operate On Windows Must Operate On The Internet Must Be Able To Track Samples Must Perform QC Must Generate Reports 4 NEMC 2011 Requirements Approximately 100 Commercial LIMS And They All Can Meet Those High Level Requirements LIMS Operate At The Granular Level Of The Organization 5 NEMC 2011 High Rate Of Failure 50% Of All LIMS Initiatives Do Not Get Fully Implemented, Do Not Meet User Expectations Or Fail Outright. 6 NEMC 2011 LIMS Requirements Decomposition Must Be Able To Track Samples •Does It Track Split Samples? •How Does It Track Redos? •Does Each Container Have A Unique Number? •How Does It Handle Broken Bottles? •Can The LIMS Record That the Sample Was Not Received? 7 NEMC 2011 Typical LIMS Evaluation Ask A Colleague Internet Search Attend A Conference Invite Vendor To Perform Demonstration This Approach Only Addresses High Level Requirements 8 NEMC 2011 LIMS Risk Components Under Estimate Configuration Vague Integration Requirements Data Migration Component Unrealistic Schedule Lack of Sufficient Budget 9 NEMC 2011 LIMS Selection Systematic Approach Work Process Evaluation and Requirements Analysis Develop Request for Proposal and Score Results Vendor Demonstrations and Score Results 10 NEMC Work Process And Requirements Analysis Interviews • Include All Stakeholder Groups • Segment By Functional Area Decompose Requirements Prioritize 11 NEMC 2011 Begin SemiVoa Analysis or Data Review Sequence File LIMS Review Data Target System Yes Re-Analyze Sample? Tune Instrument Analyst Notification No Tune Pass? Create Control Charts Yes No No Pass QC? Refer To Data Review Process Update Status Print Charts Yes Data Transfer Calculate Limits Run Calibration Sample Storage No No Calibration Pass? Dispose of Sample? Yes Yes Sample Analysis Discard Sample Please Describe How Your System Conforms To The Semi-Volatiles Analysis and Data Review Process _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 12 NEMC 2011 Requirements Matrix Number 6 6.1 6.2. 6.3. 6.4. 6.5. 6.6. 6.7. 7 7.1 7.2. 7.3. 7.4 7.1.1. 7.1.2. 7.1.3. 7.1.4. 7.1.5. 7.1.6. Type Priority State Description C 1 The LIMS should contain a Calendar with scheduling capabilities F 1 FN The calendar should be public to all groups F 1 FN The system should allow for individual group calendars F 1 The calendar should allow for coordinating/organizing sampling schedules FN F 1 date The calendar should display projects according to their projected collectionFN F 1 FN The calendar should display the project name F 1 FN The calendar should display the projected number of samples F 1 FN The calendar should display the analyses method C 1 The LIMS must capture Project/permit information F 1 FN The system must capture Project/permit name F 1 FN The system must capture the permit number, if applicable C 1 FN The system must capture the name of the project manager C 1 FN The system must capture the contact information C 1 FN Contact name C 1 FN Contact phone number C 1 FN Contact email (if any) C 1 FN Contact web address (if any) C 1 FN Fax (if any) C 1 FN Cell phone (if any) 13 Vendor Response Comments NEMC 2011 Request For Proposal RFP Components • Business Overview • Organizational Structure • Work Process Descriptions • Process Flow Diagrams • Requirements Matrix • Vendor Response Forms 14 NEMC 2010 RFP Evaluation Conformance To Requirements (Weighted Evaluation) Industry Experience Company Profile Cost 15 NEMC 2011 LIMS RFP Evaluation Score Sheet Line Section Score 1 Item B: Proposer's Questionnaire, Questions 11, pg. 63 of RFP 2 Item B: Proposer's Questionnaire, Questions 13, pg. 63 of RFP 3 Item C: System Requirements Response Form, pgs. 65-156 of RFP 4 Item D: Process Flows, Sample Receipt, D1, pg. 158 of RFP 5 Item D: Process Flows, Volatile Analysis, D2, pg. 159 of RFP 6 Item D: Process Flows, Semi-Volatile Analysis, D3, pg. 160 of RFP 7 Item D: Process Flows, Air Analysis, D4, pg. 161 of RFP 8 Item D: Process Flows, Metals Analysis, D5, pg. 162 of RFP 9 Item D: Process Flows, Wet Chemistry, D6, pg. 163 of RFP 10 Item D: Process Flows, Toxicity, D7, pg. 164 of RFP 11 Item D: Process Flows, Microbiology, D8, pg. 165 of RFP 12 Item D: Process Flows, Ocean Assessment, D9, pg. 166 of RFP 13 Item D: Process Flows, Process Control, D10, pg. 167 of RFP 14 Item E: Vendor Product Information, Current Products, Configuration and Migration Path, pgs. 168-169 of RFP 15 Item E: Vendor Product Information, Support and Updates, pgs. 170-171 of RFP 16 Item E: Vendor Product Information, System Implementation, pg. 173 of RFP 16 NEMC 2011 Product Demonstration Demonstrate How System Conforms To Requirements and Workflows Not A Sales Demonstration Standardize Demonstration Using Custom Demonstration Scripts • Vendor and Product Overview • Demonstration Data • Demonstration Tasks 17 NEMC 2011 Functional Business Area: Project Creation Demo Script No.: 2 Description: Demonstrate how to create and modify a project. Demonstrate how to create bottle kits, labels and Chain-of-Custody forms. Demonstrate how to create ad hoc sampling events. Ste p Req. # Requirement Description Evaluation Comments 1 N/A Prior to the demonstration date, enter the information described in Section 4.1. 2 4.5 Add a sample location described below to the existing project named “Hyperion NPDES”: Location: Location C Client Contact: Mark Client Composite Sample Collection Date: 7/13/07 Project Manager: Mas Dojiri Date Due: Default TAT Add the same parameters and associated data to this sampling location that have been previously added to the other locations (Aluminum, Beryllium, Cadmium). 3 4.5, 4.8, 4.9 Modify the schedule of the “Hyperion NPDES” project based on the information below: Location: Location C Parameter: MBAS Sampling Frequency: Monthly 4 1.3 Print a bottle list kit for the “Hyperion NPDES” project. 5 N/A Change the bottle lot numbers to reflect the current lot in the “Hyperion NPDES” project. 6 7.1 Print the bottle labels for the “Hyperion NPDES” project. Labels should include individual bottle tracking information. 7 6 Print the Chain-of-Custody forms for the “Hyperion NPDES” project. 18 NEMC 2011 Demonstration Do’s and Dont’s Schedule Enough Time If You Don’t See it - Ask Keep To The Scripts The Goal Is Not To Trick The Vendor 19 NEMC 2011 Cost Analysis Compare Apples To Apples Licenses Services Support Cost Should Include All Demonstrated Functionality Level of Effort Must Make Sense 20 NEMC 2011 Summary LIMS Implementations Are High Risk A Systematic Approach Will Reduce The Risk An Experienced Partner Can Assist With Implementing A Systematic Approach Results In The Selection of the Proper LIMS With A realistic Schedule and Budget 21 Questions New York . West Palm Beach . Boston . Philadelphia . Kansas City . Los Angeles 22 www.astrixtechgroup.com
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