Who is your target audience?

Pharmaceutical & Biopharmaceutical

companies

What’s (the essence of) your message?

Change control management for Computerized
Systems life cycle at Health Care Industry

Why is this message relevant/important to

them?
· (what’s their problem, question,
challenge…)
How can we help them after reading?
· (e.g. which service can we offer to solve
their problem)
It is necessary to talk about the Computerized
Systems life cycle activities during operational
phase.
We can advise on the monitoring of the
different stages of the life cycle of
computerized systems and the considerations
to be taken into account for their correct
management.

Main keyword(s)  Computer system

 Life cycle
 Change control management
Working title Change control management for Computerized
Systems life cycle at Health Care Industry
Short summary for Google (200 characters max. if All systems change, and the changes must be
possible) controlled.

Change control management for pharma computerized systems

The life cycle for computerized systems described in the GAMP 5 guide indicates that
during the operation phase, systems are susceptible to changes and that these must be
managed through a change control system that allows the implementation of
improvement changes without compromising established processes or generated
records and with minimum interruption to services.
Also the General Principles of Software Validation; Final Guidance for Industry and FDA
Staff indicates:

“Whenever software is changed, a validation analysis should be conducted not just

for validation of the individual change, but also to determine the extent and impact
of that change on the entire software system. Based on this analysis, the software
developer should then conduct an appropriate level of software regression testing
to show that unchanged but vulnerable portions of the system have not been
adversely affected. Design controls and appropriate regression testing provide the
confidence that the software is validated after a software change”

Operational Change and Configuration Management

GAMP 5 guideline talks about Operational Change and Configuration Management. It is
described that both activities are closely related and should be considered in parallel,
particularly when evaluating impact of changes.
As a summary operational change and configuration management requires following
considerations:

Operational change Configuration management

 Description of the proposed change  Configuration identification (Components to
 Document and justify the change be configured)
 Evaluate risk and impact of the change  Configuration control (How to perform
 Accept or reject the request for change configuration changes)
 Develop and verify the change  Configuration status Accounting (How to
 Approve and implement the change document configuration changes)
 Close the change  Configuration evaluation (How to verify
configuration changes)

Types of Changes
Type Description
Like for like replacements: Designed to control material usage
System Administration Changes: Involve changes to system components
Emergency changes: Should be based on risk and should be subsequent reviewed,
documented, verified, and approved.
Temporary changes: These are planned changes for a limited period. New or increased risks
should be assessed and managed.
Global Changes: Changes related to global implemented computerized systems.

The change control procedure will need to take account of the corresponding
procedures and records used by suppliers, integrators and other parties contracted to
support the system and applications.
Conclusion: All systems change, and the changes must be controlled through the
corresponding change control management described into corresponding procedure.

GAMP 5 guideline describes Operational Change and Configuration Management to

perform the improvement changes without compromising established processes or
generated records and with minimum interruption to services

New in systems validation and need help with kick off? Our experts are happy to assist
you with the best validation program according to your available resources. Please do not hesitate to
contact us if you have any questions.

References:
 PIC/S GUIDANCE GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP”
ENVIRONMENTS, PI 011-3 25 September 2007.
 GAMP 5 A risk based approach to compliant GxP Computerized System, ISPE, 2008.
 https://www.scilife.io/blog/gamp5-for-gxp-compliant-computerized-systems.
 https://healthcareitskills.com/information-technology-change-control-process-change-board/
 General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document
issued on: January 11, 2002.