Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.
Technically, if a validated system is changed, the conditions established during validation are no longer true and the system is not longer validated. In practice, it is not necessary to completely revalidate the system when making small changes to systems. Major changes will require additional re-validation and critical changes could trigger and entire re-validation of a system.
One useful tool to determine the extent of revalidation is Risk Assessment. By reviewing the original validation requirements, and evaluating the new risks introduced through the changes to the system, the Risk Assessment process can help determine which sections of the system will need re-testing.
How can Ofni Systems help you?
|
Typical Steps in a Change Control project are:
- Request the Change - The System Owner formally requests a change to the system.
- Assess the Impact of the Change - Before the change is made, the system owner and other key stake holders, including Quality, determine how the change will affect the system.
- System Development in a Safe Environment - Changes should be initially made away from the validated system. For computer systems, this can mean testing in a Sandbox environment. For equipment, process or method validations, this usually means implementing the change during a period when manufacturing has shut down.
- System Testing/Re-Validation - Before changes are accepted, the system is validated to ensure they system accuracy, reliability and consistent intended performance.
- Implementation of the Change - The changed system is released to the site and users are trained on changes to the system. For computer systems, this means pushing the changes out to general users. For equipment, process or method validation, this means introducing the system into the larger production process.
Frequently Asked Questions
Q: Do I need to revalidate a system every time I make a change?
A: It depends on the scope of the change, the structure of the system and any new risks introduced into the system. Changes to critical components of a system might require a complete revalidation, but smaller changes might only require testing of the changes.
Don't see your question answered?
Contact us and ask us your question.
Additional Resources
Validation Document Resources
|
|
