John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder. That was just one of many times that he observed teams not taking a risk-based approach to systems validation.
by ZenQMS