21 CFR Part 11 – Log Aggregation, Storage and Monitoring Regulatory Requirements – (Part 1)
What is 21 CFR part 11? 21 CFR Part 11 is the FDA’s regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system. In March of 1997, the United States FDA issued regulations that established the criteria for acceptance by the FDA of […]