By Kelly Stanton
Published in: Qualio Blog
Published on: October 5, 2022
Key strategies for change control -Having a strong change control process in place is critical for compliance. -Developing a regulatory notification decision flowchart or matrix now can make your life much easier later. -Don’t forget to document everything! You’ll need to document every piece of the change control process from identification through to approval and implementation. -Using a software system for tracking the MANY moving pieces during a change control process can minimize chaos and ensure that steps are not skipped. -Quality or engineering cannot complete the change control process in a silo, it is a team effort that functions best when it has input from everyone. -Don’t forget the follow-up activities to make sure that the change was effective and didn’t introduce any other problems. Key Words: Risk, 9001, Regulation
Change Control • Change Control • Data Integrity • Quality • SOPS • Systems • Tools