www.diahome.orgDIA 6th European Validation Workshop, Amsterdam, 2007.
Building Change into Process
David BridgesDirector, eChange Solutions Limited
eChange SolutionsLimited
www.diahome.org
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.
www.diahome.org
Biometrics systems
Query Management
RDECDMS
Reporting & Statistical Analysis
Submission Compilation & Publishing
Work Tracking
Resource Management
Image Management
www.diahome.org
Biometrics systems
Query Management
RDECDMS
Reporting & Statistical Analysis
Submission Compilation & Publishing
Work Tracking
Resource Management
Image Management
www.diahome.org
Biometrics systems
Query Management
RDECDMS
Reporting & Statistical Analysis
Submission Compilation & Publishing
Work Tracking .
Resource Management
Image Management
www.diahome.org
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
www.diahome.org
Scope :
• Requirement
• Design
• Development
• Testing
• Training
• Release
• Support planning
System introduction / major upgrade
CDMS
Validation
www.diahome.org
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
www.diahome.org
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
www.diahome.org
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.
www.diahome.org
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.
www.diahome.org
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
www.diahome.org
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
www.diahome.org
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
www.diahome.org
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
www.diahome.org
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)
www.diahome.org
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.
www.diahome.org
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.
www.diahome.org
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.
www.diahome.org
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)