The FDA’s 21 CFR Part 11 regulation outlines requirements for electronic records and signatures for medical device companies. Part 11 compliance is complex, going far beyond just having validated systems and audit trails. Many companies believe they are compliant when in reality they are not fully meeting the FDA’s expectations. What Does 21 CFR Part … Read more

Computerized system validation is required by medical device regulations to ensure quality, safety, and effectiveness. Systems that fail to properly validate are at risk of FDA citations, product delays, or worse. However, many companies struggle to implement validation appropriately and efficiently. What is Covered Under Computerized System Validation? Validation applies to any computerized systems that: … Read more