Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
FDA has given device establishments a gift in regard to the vagueness of the RI requirement. It is up to each device establishment to decide how much RI is required. However, at the end of the day the approach for RI must be defendable during an agency inspection, and when in doubt, the approach to RI should be risk-based.
Device History Records are not optional. So do not be that Chief Jailable Officer that has to sit across from that FDA investigator without the documented evidence of compliance needed to defend your establishment’s QMS (or lack of it).
Remember these takeaways: When nonconforming product is identified, quickly bag it and tag it. Make sure the disposition process is well documented, including evidence of an investigation to support it; and use a locked quarantine.
If an organization fails to practice cGMP compliance, chances are good that either the QMS is poorly constructed or the management team is clearly disconnected from the QMS process.
Do not be that establishment that fails to fully establish procedures or collect relevant information needed to support claims of compliance with the QSR.
Not granting the agency full access for the purpose of conducting an inspection is going to end badly for the offending establishment. The staunch reality of failing to grant FDA access for an inspection is free admission to regulatory purgatory until as such time access is granted and a re-inspection performed.
How can medical device companies establish end-to-end regulatory compliance as a strategic initiative?