Digital Compliance and Data Integrity: Mastering 21 CFR Part 11

Medical Device Global Market Access

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? • What are the specific requirements for system validation and access controls? • What makes an electronic signature compliant under Part 11? • Is a time-stamped audit trail required for all electronic records? • How did the FDA's guidance from August 2003 affect the interpretation of this rule? • What is the difference between relying on an electronic record versus a paper printout? • What three pieces of information must be associated with every electronic signature? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.