The Evolution of Master DataThe Evolution of Master Data ... Evolution of Mas… · The Evolution...

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)

Results Count www.labware.com© LabWare 2012 [© LabWare 2012 [22]]

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


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


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


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


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


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?


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.


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


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


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


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


Master Data Project


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


The New Process


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


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.


Master Data Project


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.


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


Questions


Date post:	07-Jul-2018
Category:	Documents
Upload:	hoangdat
View:	224 times
Download:	0 times

The Evolution of Master DataThe Evolution of Master Data ... Evolution of Mas… · The Evolution...

Documents