The Ultimate Guide to Change Control for Life Sciences Companies
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
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