www.diahome.orgDIA 6th European Validation Workshop, Amsterdam, 2007.

Building Change into Process

David BridgesDirector, eChange Solutions Limited

eChange SolutionsLimited

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Introduction

• Impact of change on validated systems• How to manage change• Contrast with processes and recourses used

in new system introduction / major upgrades.• Drawing examples from the European

Biometrics Department of an (un-named) global research based pharma. Company.

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Biometrics systems

Query Management

RDECDMS

Reporting & Statistical Analysis

Submission Compilation & Publishing

Work Tracking

Resource Management

Image Management

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Biometrics systems

Query Management

RDECDMS

Reporting & Statistical Analysis

Submission Compilation & Publishing

Work Tracking

Resource Management

Image Management

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Biometrics systems

Query Management

RDECDMS

Reporting & Statistical Analysis

Submission Compilation & Publishing

Work Tracking .

Resource Management

Image Management

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Data

Extraction

Major System Change

Query ManagementQuery Management

RDERDE

Image Image ManagementManagement

CDMS

Reporting & Reporting & Statistical Statistical AnalysisAnalysis

Data

transfer

Data entry

OCR

Query Generation

Major change is usually focuses on a single system and it’s interfaces

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Scope :

• Requirement

• Design

• Development

• Testing

• Training

• Release

• Support planning

System introduction / major upgrade

CDMS

Validation

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System introduction / major upgrade

CDMS

Usually :

• Organized as a project

• High level sponsorship (business & technical)

• High visibility

• “Business” involvement

• Best practice in– Change management– Configuration management– Risk management

May also :

• Form part of a change programme

• Benefit from project office

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Data

Extraction

Validation of system

Query ManagementQuery Management

RDERDE

Image Image ManagementManagement

CDMS

Reporting & Reporting & Statistical Statistical AnalysisAnalysis

Data

transfer

Data entry

OCR

Query Generation

Validation focuses on a single system and it’s interfaces

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Validation paradigm

Investigator FDA

A chain of validated systems :

Each of which has been validated to demonstrate its fitness for purpose.

That together ensure the authenticity, integrity, confidentiality and signer non-repudiation of records from the investigator to

regulatory authority.

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So What is the problem !• These system do not exist in a static environment.• In fact, the environment is less “under control” that

the systems !• Changes to :

– Organization structure

– Staff

– Processes (SOPs)

– Use of system

– IT infrastructure

– System functionality (minor changes, bug fixes)

• All have potential to compromise the effective operation of the system.

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Scale of change : Biometrics

• At any one time involved with approx. 20 drugs. 4 in phase III and a further 4 post primary submission.

• Estimated duration of involvement with drug that is approved is 15 years

Biometrics involved with drugs in phase 1-3 & also drugs where primary submission complete but further submission (country, indication) required.

I Post SubmissionIIIII

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Think about it !

• What changes have occurred in your organization in the last 15 years ?– Organization structure– Staff– Processes (SOPs)– Use of system– IT infrastructure

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RDE 3

Image Management 2

CDMS 3

Query Management 4

Report & statistical analysis 2

Submission Compilation and Publishing 1

Work Tracking >4

Resource Management >5

System Duplication

• Systems change but data migration is risky and expensive• This leads to system duplication

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Managing change

Management of change to :• Organization structure• Staff• Processes (SOPs)

All require similar processes and resources• Change management• Configuration management• Risk management

• Use of system• IT infrastructure• System functionality (minor/bugs)

• Change control boards

• Designated staff

• Inventories

• Decision makers

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Managing change

Management of change to :• Organization structure• Staff• Processes (SOPs)

All result in similar outcomes• Document and proceed• Undertake partial risk-based validation• Undertake full validation

• Use of system• IT infrastructure• System functionality (minor/bugs)

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Analysis of validation events

Over a three year period there were 41 changes to systems or processes requiring full or partial re-validation impacting the Clinical Data Management System (CDMS). Half related to upgrades of the CDMS system itself, while the remainder related to auxiliary systems and infrastructure products such as the database, SAS and the operating system.

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Analysis of validation events

Of the 41 events• 11 were infrastructure driven :

– 4 database– 9 Server– Of these 2 were driven by infrastructure change required by

another validated system

• 2 were database migration projects• 12 were releases of new functionality (including bugs)• 16 were bug-fix releases• Significant number of infrastructure and process

deemed not to require re-validation by CCBs.

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Final points

• Can not achieve compliance by focusing on change management of the system alone.

• Most organizations have multiple CCB’s (& they don’t talk to each other !).

• One man’s focus of responsibility is another man’s risk.

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Practical advice

• Determine what the sources of change are and how they are controlled

• Encourage best practice within each domain

• Encourage communication and mutual support

• Put in place safety net (Support Plan)

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Questions ?

Many Thanks

Slides can be downloaded from :www.echangesolutions.com

from Monday

Or leave me a business card and I will e-mail them to you.