Transcript presentation here

Building Change into Process
David Bridges
Director, eChange Solutions Limited
www.diahome.org
DIA 6th European Validation
Workshop, Amsterdam, 2007.
eChange
Solutions
Limited
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
RDE
CDMS
Reporting & Submission
Statistical
Compilation
Analysis
& Publishing
Image Management
Work Tracking
Resource Management
www.diahome.org
Biometrics systems
Query Management
RDE
CDMS
Reporting & Submission
Statistical
Compilation
Analysis
& Publishing
Image Management
Work Tracking
Resource Management
www.diahome.org
Biometrics systems
Query Management
RDE
CDMS
Reporting & Submission
Statistical
Compilation
Analysis
& Publishing
Image Management
Work Tracking
.
Resource Management
www.diahome.org
Major System Change
Query Management
Query Generation
RDE
Data
transfer
CDMS
Image
Management
Data
entry
Reporting &
Data
Statistical
Extraction Analysis
OCR
Major change is usually focuses on a single system and it’s interfaces
www.diahome.org
System introduction / major upgrade
CDMS
Scope :
• Requirement
• Design
• Development
• Testing
• Training
• Release
• Support planning
www.diahome.org
Validation
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
Validation of system
Query Management
Query Generation
RDE
Data
transfer
CDMS
Image
Management
Data
entry
Reporting &
Data
Statistical
Extraction Analysis
OCR
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
Biometrics involved with drugs in phase 1-3 & also drugs
where primary submission complete but further submission
(country, indication) required.
I
II
III
Post Submission
• 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
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
System Duplication
• Systems change but data migration is risky and expensive
• This leads to system duplication
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
www.diahome.org
Managing change
Management of change to :
• Organization structure
• Staff
• Processes (SOPs)
• Use of system
• IT infrastructure
• System functionality (minor/bugs)
All require similar processes and resources
• Change management
• Configuration management
• Risk management
•
•
•
•
Change control boards
Designated staff
Inventories
Decision makers
www.diahome.org
Managing change
Management of change to :
• Organization structure
• Staff
• Processes (SOPs)
• Use of system
• IT infrastructure
• System functionality (minor/bugs)
All result in similar outcomes
• Document and proceed
• Undertake partial risk-based validation
• Undertake full validation
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)
www.diahome.org
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.
www.diahome.org