Focus on Pharma Episode 14: Y2K Redux? Pharma Needs to Go Back to Square One With 21 CFR Part 11, says Johnny Guerra

Many companies still don't invest in the validation and QbD approach needed to ensure data integrity, says FDA veteran, consultant Johnny Guerra. Failing to examine requirements during the process design stage, and to test the cGMP limits of software and IT, leaves manufacturers potentially liable at a point when a product recall may be their only option.