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Partnering to provide “Best Practice” Migration Results: When compliance and business risks mandate “Getting it Right”

January 25, 2012 Dr. Rodney Lemery Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc.

Rick Higger President Valiance Partners, Inc.

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Agenda

• Summary of the Migration Challenge • State of the Industry • Solution: Accel-Migrate Assessment

The Business Process Application/Technology Compliance

Process Reengineering Migration

• Discussion

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Migration Challenge • The success rate for the data

migration portion of projects: 16% - 60%

1. Poorly defined scope

2. Inability to assess and address data quality

3. Inadequate testing

4. Lack of support from business community

5. Absence of Methodology

6. Inexperienced team

Howard 2007 & 2011

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Migration Challenge: Safety Data Management

• ETL: widespread, there aren’t built-in facilities for safety systems

• Data profiling techniques must be tailored to safety specific concerns, e.g., standardize coding

• E2B: a standard, but migrations often include 100s of non-standard fields

• Validation is labor intensive and relies on random samples that will miss anomalies

• Functional gaps identified mid-stream require an inordinate sum of time to resolve.

• The result De facto approach is based on custom scripting & sample-based testing

Iterative in nature, indeterminate results

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What the Industry Seeks

• A track record of success Must include multi-department reengineering

success

• Safety Data Specific Data Profiling Standardization of dictionaries & coding schemes

• Out-of-box migration solution • Comes pre-configured

• Modification through configuration

Eschew custom coding/scripting

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What the Industry Seeks (cont.)

• Automated data migration testing to verify 100% of the migrated data

• Sampling’s “acceptable level of error” are simply not acceptable

• Anticipate dry runs

• Evidence viable for FDA audit

• The process must be user-driven • Technology can identify migration issues, users

must define their resolution

• UAT the data in the new system Verify the integrity of reporting

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What the Industry Seeks (cont.)

• Clear agenda for change documented (O’Carroll, et. al., 2003, p.42) • Business and IS views justified for the required

expense

• Proper training and process re-engineering of staff is key to success • Sharma and Yetton (2007) have found that

successful IS implementations required a training component when the system is both technically complex and task interdependence between the software and the business use are present Complex processing re-engineering often

requires the assistance of skilled outside resources to assist in software configuration and change management needs

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Our Solution: Accel-Migrate • Assessment

• Process reengineering requirements

• Migration high-level scoping and data discovery

• A fixed-fee engagement for well-scoped projects

• Migration Effort

• A company-centric migration, which includes:

Standardization of coding & dictionary values

▫ MedDRA, Product, WHO

• User-centric review process

• 100% Automated testing of the migrated results

• Validation – inclusive of test evidence for all migrated data

• Licensing for TRUmigrate, TRUcompare and application specific configurations, e.g., AERS to Argus

• If required, application configuration changes as well

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Unique Methodology

Migration Planning

Analysis & Pre-Migration

Testing

Refine OOB Configurations

Dry Runs 100% Automated

Testing

User Acceptance Testing

Validation & Production Migration

Production Migration

• Pre-migration testing – identify data cleansing & data enrichment requirements • Verify WHO, MedDRA & product dictionaries

• Dry runs – Automated testing to minimize the iterative test debug cycle

• Validation – Test 100% of the migrated data, no sampling

• Parallel Process reengineering allows for simultaneous process and technical work • Sometimes process work affects the configuration of the final system, which in turn

affects the migration effort

Parallel Process

Re-engineering

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Expert Partners Our safety consultants have an average of 15 years of experience in the field of product safety and have observed the use of safety software at many companies

We bring a broad and varied understanding of industry practice

▫ CROs, Device, Biotech and Pharma companies

Our past experience in process reengineering is proven

▫ SOP re-writing, change management, system configuration changes

Client requirements from the modest to over 1+ Million cases

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Process Reengineering Methodology

• Convening a process improvement team

• Extensive review of the existing quality documentation from the organization(s) and then performed

• Generate a formal strengths, weaknesses, opportunities and threats (SWOT) analysis • Contextual and often focused on regulatory differences among

countries

• Use the SWOT results to plan an SOP/WI development strategy

• Facilitate meetings to work through all identified SOP/WI updates or creation

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Process Reengineering: Recent Example

Current Control Number

Document Title

CAN SOP.01 Canadian SOP governing case processing FRA SOP.01 French SOP governing case processing FRA WI.01 French WI governing the use of the case management system FRA WI.02 French WI governing the administration of the case management system FRA WI.03 French WI governing the nullification and reinstating of cases FRA WI.04 French WI governing change management of the case management system GBR SOP.01 UK SOP governing case processing GBR SOP.02 UK SOP governing the use of the case management system GBR SOP.03 UK SOP governing the administration of the case management system GBR SOP.04 UK SOP governing the nullification and reinstating of cases GBR SOP.05 UK SOP governing change management of the case management system USA SOP.01 US & South America Argus Case Entry USA SOP.02 US & South America Argus Contacts, Routing and Action Item use USA SOP.03 US & South America Argus Configuration

• Integration of a U.S.-based company with a global company

• List of original Quality documents requiring analysis and consolidation

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Process Reengineering: Recent Example

• Document inconsistencies, and content problems are collected and expressed in the SWOT table

• Facilitate meetings to cover the SWOT results and map a plan for consolidation

Current Documents

Strengths Weaknesses Opportunities Threats

CAN SOP.01 Refers to guidelines

on Health Canada –

this helps to lower

document maintenance

Too detailed for

an SOP and not in

alignment with the

similar global quality documents

Separate WI

should be created

for periodic

reporting outside of

this quality document

The lack of complete

periodic report

processes could lead to

noncompliance with regulatory agencies

USA SOP.01 Only quality

document of use of

the Argus application

for case

management

Does not include

any country but

the US and South America

Should be updated

for rest of world (ROW)

Current US process

doesn’t match German

and French case

management

requirements leading to

potential inconsistencies

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Process Reengineering: Recent Example

• Final global SOP and WI governing the complete process of case management and reporting

Current

Control Number

Document Title

GLB SOP.01 Global SOP on Case Processing Active Cases GLB SOP.02 Global SOP of Glossary of Terms GLB WI.01 Global WI for Electronic Submission Activities GLB WI.02 Global WI for Medically Significant Cases GLB WI.03 Global WI documenting Medically Significant Event List GLB WI.04 Global WI for Expectedness Completion GLB WI.05 Global WI for Writing Narratives GLB WI.06 Global WI for Argus Case Entry GLB WI.07 Global WI for Additional Information Use GLB WI.08 Global WI for Duplicate Case Processing

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TRUmigrate

• Application-aware migration Software • Broad GxP Application Support

• APIs & enhancements And Oracle, SQL Server, DB2 and ODBC as well

• Highly-configurable UI (no programming)

• Automation: Configure once, execute many times without overhead

• Strong adoption in FDA regulated market

• 300+ migrations to date

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TRUcompare

• Migration Testing: Tests 100% migration results • No manual sampling

• Configuration Console: Enables rapid configuration and validation of overall migration process

• Pre-migration testing: Profiles source data and content and identifies deviations without having to perform test migrations—Identify data cleansing requirements early in the migration process

• Reporting: Captures all relevant test results for Data Discovery, testing and validation purposes

• Specification: Automatically Generates Migration Specifications

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TRUcompare’s Automated Post-Migration Testing

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Pre-migration Testing

• Dictionary Maintenance (Product, MedDRA, WHO) • Identify any non-valid source record • User-centric management process

• Identify Error • Source NULL for mandatory fields • Truncations • Type mismatches • User-centric management process

• Duplicate identification & remediation • Define ID Rule: typically based on

patient, adverse reaction & product data • Search source system(s) • User-centric management process

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Benefits of Automated Data Migration Testing

• Total Verification: Sampling is eliminated; all migration results (100%) are tested—Turns a difficult-to-manage task into a deterministic process

• Pre-migration testing: Identify 40-60% data anomalies

• Migration Specification Accuracy: Cannot have an out-of-sync specification

• ROI: • Automated process replaces iterative sampling • Pre-migration testing start data cleansing early

• Enhanced Compliance: Enables elimination of all errors and fully documents results

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Error Types & Techniques

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Safety Data Management Customer Quotes

• “We were able to find all data anomalies, not only those identified from some samples during the rollout. This was absolutely imperative and we are looking to put our patient’s safety first. “

• “Accel-Migrate’s testing approach identified data error that would have otherwise gone into the production system.”

• “Savings were earned several times by Accel-Migrate’s migration testing process. Automated testing was re-executed based on existing configurations where manual testing would have otherwise been required for every migration test run.”

• “TRUcompare did the job without error. Its maturity level is very high. Professional support provides reliable and quick turnaround time.”

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Software & Methodology for GxP Systems

• Safety Systems • Argus Safety • AERS • ARISg • Clintrace/Empirica Trace • PV Works

• Other GXP Systems • BPCS • CSC FirstDocs® • ENOVIA® (MatrixOne®)

• EMC® Documentum® ▫ Inclusive of EDMS98, 4i, D5,

D6/6.x & DCM

• EMC® eRoom® • File shares • GxPharma • MasterControl

• More Systems • Microsoft SharePoint® 2007 / 2010 • Open Text Livelink® • Oracle Content Management • QUMAS DocCompliance® • QUMAS ProcessCompliance® • Sparta Systems Trackwise® • Lotus Notes • Pilgrim Software

• Direct Database Connections • ODBC • Microsoft SQL Server® • Microsoft Access and Excel • Oracle® • AS/400 DB2 • VAX RDBMS

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Accel-Migrate Summary

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The Result

Ability to successfully manage fixed-price migrations and process reengineering needs

● Identification of migration and process reengineering needs

● Two Phase w/ pre-migration testing in initial phase

ROI

● Consistently cost competitive

● 100% testing, nominal incremental cost for validation

● Minimal post-production support

Ability to conduct efficient POCs

● Proof of Concepts

90%+ Repeat customers

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Ways to Engage…

• For those not quite ready… • Collaborate on requirements

• For those in the midst of a migration • Refine your approach with 100% automated testing

• Migration software demonstration

• On-site proof of concept

• Looking to harmonize relevant business processes?

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References

• Howard, P. (2007). Data Migration – Research, forecast & survey results paper by Bloor Research.

• Howard, P. (2011). Data Migration 2011 paper by Bloor Research.

• O’Carroll, P. W., Yasnoff, W. A., Ward, M. E., Ripp, L. H., Martin, E. L. (2003). Public Health Informatics and Information Systems. Springer

• Sharma, R. & Yetton, P. (2007). The Contingent Effects of Training, Technical Complexity, and Task Interdependence on Successful Information Systems Implementation, MIS Quarterly, (31: 2).

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Questions & Answers

Dr. Rodney Lemery Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc.

(650) 292-5310 rlemery@biopharm.com

Rick Higger

President Valiance Partners, Inc.

(908) 334-2300 rhigger@valiancepartners.com