(One Company s Story) Eric Ellingson

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Arnold Leon Goodwin
10 years ago
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1 The Evolution of Master Data (One Company s Story) Eric Ellingson

2 Agenda Timeline of our LIMS projects Background of Catalog & Terminology The Old Process The New Process Further Evolution of Our Process Q & A (5-10 minutes) LabWare 2012 [2]

3 LIMS Timeline Phase I, October product family builds & cleanings Standard Reagent Manager (lab solutions) OOS results flagged Data entry and review Lot disposition LabWare 2012 [3]

4 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 LabWare 2012 [4]

5 LIMS Timeline Phase 2B, January 2009 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 Sample Delivery LabWare 2012 [5]

) CII Sample Tracking/ Chain of Custody Stability Management

6 Terminology Technical Design Specification (TDS) Form we use to control our Master Data (i.e. Analysis and Product Specifications Test Script Step wise manner to test the intended changes. Change Evaluation Form (CEF)- Form to evaluate any type 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 accurately made in LIMS CCR Change Control Request LabWare 2012 [6]

All CEFs go through the Lab Change Verification Form (CVF)- Form (checklist) to verify that a catalog requested

7 Terminology Catalog Change A pre-defined change that involves minor 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) Fix Something not working properly, i.e. with code or Parsing Script (CCR needed) Enhancement Change to a user requirement(s), or a change to a process (CCR needed) Example: Adding Visual Workflows module LabWare 2012 [7]

Technicality of the change is minimal and the impact is assessed using the CEF (no CCR) Fix Something not

8 Master Data Project New Lab Director = New Philosophy New project to create 329 new analysis We new we couldn t test it the old way WHY? LabWare 2012 [8]

9 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 testing. ti So we started to build our case for change. LabWare 2012 [9]

It seemed like we were spending more time with the paperwork

10 The Old Process All changes to the system required a CCR. All builds (Analysis, Product Specifications, etc.) required a test script. Test Scripts in general Required five signatures Author and pre-approval, executed by, reviewed by, and QA approval Product Specification Test Scripts Typically 8 pages with 19 steps 2 Attachments LabWare 2012 [10]

Test Scripts in general Required five signatures Author and pre-approval, executed by,

11 The Old Process Analysis Test Scripts with no calculations Example: Identification by IR Typically 10 pages with 20 steps 3 Attachments No screen shots LabWare 2012 [11]

12 The Old Process Analysis Test Scripts with easy calculations Example: Assay Titration Typically 12 pages with 19 steps 3 Attachments Five or so screen shots LabWare 2012 [12]

13 The Old Process Analysis Test Scripts with complex calculations Example: Chromatographic Impurities Typically 40 pages with 130 steps 5 Attachments Thirty or so screen shots LabWare 2012 [13]

14 Master Data Project LabWare 2012 [14]

15 The New Process We took a risk based approach Define catalog changes Changes that do not require CCR Created Change Verification Forms No longer run test scripts for catalog changes LabWare 2012 [15]

16 The New Process LabWare 2012 [16]

17 The New Process Only builds with calculations require a Change Verification Form Other builds require a TDS sign off. Change Verification Form Require three signatures Author, Approver, and QA approval Product Specification Approver signs off on TDS using Product Verification Report 1 Attachment LabWare 2012 [17]

Change Verification Form Require three signatures Author, Approver, and QA

18 The New Process Analysis with easy or complex calculations Requires Change Verification Form Approver signs off on TDS using Analysis Verification Report 2 Attachments One or two screen shots Change Verification Form is where the Approver manually verifies all calculations. LabWare 2012 [18]

Verification Report 2 Attachments One or two screen shots Change

19 Master Data Project LabWare 2012 [19]

20 Master Data Project The Old Process LOE 4700 hours The New Process LOE 2300 hours The message think about how you are going to control your master data before you go live. LabWare 2012 [20]

21 Further Evolution of Our Process Remove QA Approval for Level 2 changes Approval Manager for Level 1 changes Have approvers check the Verification (Analysis and Product Spec) Reports electronically. Go to an all electronic testing of Master Data LabWare 2012 [21]

22 Questions LabWare 2012 [22]

The BlazeLIMS Family of Products Functional Specs V5.5

The BlazeLIMS Family of Products Functional Specs V5.5 These Functional Specs have been organized according to the workflow of a comprehensive laboratory that uses all the LIMS functions. Depending on