Computer System Validation - FDA Warning Letters Case Studies - Lessons Learned

Description

​Computer System Validation – FDA Warning Letters Case Studies – Lessons Learned

In the past few years, the US Food and Drug Administration (USFDA) has issued numerous warning letters, import alerts & seizures to manufacturers of finished products for violation of the current good manufacturing practice regulations. In this course, Specific Warning Letters issued by the USFDA are selected as case studies and analyzed for non-compliance of data integrity, data security, data transfer, audit trails, electronic records & signatures, software validation, and computer system validation following 21 CFR part 11 and other applicable guidelines. A detailed review of selected Pharmaceutical Manufacturers Warning Letters provides useful insights into where the FDA focuses and where pharmaceutical manufacturers have deficiencies in computer system validation compliance. Reviewed and analyzed letters show that the FDA is taking a more system-based approach to assessing cGMP compliance and paying close attention to such data integrity and computer system validation requirements. Our review and analysis of selected Warning letters deficiencies will help pharmaceutical companies to identify data and systems that are subjected to 21CFR Part 11 and develop systems more effectively to avoid the Form 483 or Warning Letters.