9 Tips To Comply with 21 CFR Part 11

For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for the companies who are subjected to FDA inspections. Organizations are required to follow best practices for maintaining the compliance and quality process by following the 21 CFR Part 11 regulation. However, as more medical device manufacturers have moved from paper based to electronic quality systems, they have become subject to the new set of regulations: 21 CFR Part 11. When the regulation is viewed as a whole, we can see the goal is quite simple, to legitimize digital records by giving credibility to electronic signatures, audit trails, and digital authority checks.

Here are some significant points and tips to be aware of to ensure you and your organization achieve compliance with 21 CFR Part 11: