Q: At our company, we don’t have an issue with validating production software or firmware, but we do make improvements to software and firmware on the production floor.
Do you have any insight as to when and if FDA expects prior approval when we make these changes?
A: If you make improvements to production software or firmware, then you are making a change to a validated system.
So you need to have a change management/maintenance procedure that requires you to assess the change against your existing system and software requirements. In addition, you need to assess the change against your existing risk assessments.
“Your procedure should require you to perform any necessary installations, operational checks, and performance evaluations.”
Your procedure should require you to perform any necessary installations, operational checks, and performance evaluations.
These actions are necessary to ensure the changed system will continue to conform to your requirements and perform as intended and as needed by your users.
This approach is what FDA normally describes as “re-validation” after a change has been made.
We prefer to think of it as performing the necessary tests and evaluations to demonstrate that you have maintained a validated state, even though you have made improvements.
Answered by the staff of EduQuest. For further information and training on software and systems validation, plan to attend EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance class.