Digital Compliance and Data Integrity: Mastering 21 CFR Part 11

Medical Device Global Market Access · Aug 13, 2025 · 3m

This episode provides a comprehensive overview of the U.S. FDA's 21 CFR Part 11, detailing the essential compliance requirements for medical device companies using electronic records and signatures. We explore the core tenets of system validation, data integrity through audit trails, and the standards for legally binding electronic signatures, providing a clear roadmap for navigating this critical regulation. Key Questions: • What is 21 CFR Part 11 and when does it apply to a medical device company? • How can we ensure our electronic records are considered trustworthy and reliable by the FDA?…