The Evolution of Master DataThe Evolution of Master Data (One Company’s Story)
Eric Ellingson
Agenda
Timeline of our LIMS projectsp j Background of Catalog & Terminology The Old Process The Old Process The New Process Further Evolution of Our Process Further Evolution of Our Process Q & A (5-10 minutes)
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LIMS Timeline
Phase I, October 2006,• 5 product family builds & cleanings• Standard Reagent Manager (lab solutions)• OOS results flagged• Data entry and review• Lot disposition
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LIMS Timeline
Phase 2A, mid-2008,• Batch Manager• Instrument Manager• Empower Interface• Balance Interface• Reports• Standard Reagent Manager upgrade (Barcoding)
All Raw Materials into LIMS• All Raw Materials into LIMS
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LIMS Timeline
Phase 2B, January 2009, y• Remaining Products built into LIMS• Instrument Interfacing (titrators, pH meters, etc.)• CII Sample Tracking/ Chain of Custody• Stability Management• Validation/Cleaning Project Management• Special Sample Management
Inventory (Retain) Management• Inventory (Retain) Management• Sample Delivery
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Terminology
Technical Design Specification (TDS) – Form we use t t l M t D t (i A l i d P d tto control our Master Data (i.e. Analysis and Product Specifications
Test Script – Step wise manner to test the intended hchanges.
Change Evaluation Form (CEF)- Form to evaluate anytype of proposed change in LIMS. All CEFs go through the Lab
Change Verification Form (CVF)- Form (checklist) to verify that a catalog requested change has been y g gaccurately made in LIMS
CCR – Change Control Request
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Terminology
Catalog Change – A pre-defined change that involves g g p gminor changes and does not impact the functionality of the system. Technicality of the change is minimal and the impact is assessed using the CEF (no CCR)p g ( )
Fix – Something not working properly, i.e. with code or Parsing Script (CCR needed)E h t Ch t i t( ) Enhancement – Change to a user requirement(s), or a change to a process (CCR needed) • Example: Adding Visual Workflows modulep g
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Master Data Project
New Lab Director = New Philosophyp y
New project to create 329 new analysis New project to create 329 new analysis
We new we couldn’t test it the old way We new we couldn t test it the old way
WHY? WHY?
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Master Data Project
The Old Process Stunk It’s what we went live with so we were
stuck with it. It seemed like we were spending more time
with the paperwork than with building and t titesting.
So we started to build our case for change.
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The Old Process
All changes to the system required a CCR.g y q All builds (Analysis, Product Specifications, etc.)
required a test script.T t S i t i l Test Scripts in general• Required five signatures• Author and pre-approval, executed by, reviewed by, and QA
approval
Product Specification Test ScriptsT i ll 8 ith 19 t• Typically 8 pages with 19 steps
• 2 Attachments
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The Old Process
Analysis Test Scripts with no calculationsy p• Example: Identification by IR• Typically 10 pages with 20 steps • 3 Attachments• No screen shots
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The Old Process
Analysis Test Scripts with easy calculationsy p y• Example: Assay Titration• Typically 12 pages with 19 steps • 3 Attachments• Five or so screen shots
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The Old Process
Analysis Test Scripts with complex y p pcalculations• Example: Chromatographic Impurities• Typically 40 pages with 130 steps • 5 Attachments
Thi t h t• Thirty or so screen shots
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Master Data Project
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The New Process
We took a risk based approachpp Define catalog changes
• Changes that do not require CCRg q Created Change Verification Forms
• No longer run test scripts for catalog changesg p g g
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The New Process
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The New Process
Only builds with calculations require a Change y q gVerification Form
Other builds require a TDS sign off.Ch V ifi ti F Change Verification Form • Require three signatures• Author, Approver, and QA approval
Product Specification• Approver signs off on TDS using Product
Verification Report• 1 Attachment
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The New Process
Analysis with easy or complex calculationsy y p• Requires Change Verification Form• Approver signs off on TDS using Analysis
Verification Report• 2 Attachments • One or two screen shots• One or two screen shots• Change Verification Form is where the Approver
manually verifies all calculations.
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Master Data Project
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Master Data Project
The Old Process LOE• 4700 hours
The New Process LOE• 2300 hours
The message…think about how you are i t t l t d t b fgoing to control your master data before
you go live.
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Further Evolution of Our Process
Remove QA Approval for Level 2 changesQ pp g Approval Manager for Level 1 changes Have approvers check the Verification Have approvers check the Verification
(Analysis and Product Spec) Reports electronically.
Go to an all electronic testing of Master Data
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Questions
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