Training & Documentation Deviations – Page 5

Document revisions uncontrolled during deviation investigation – QMS remediation failure

The initial symptoms of the uncontrolled document revisions manifested in multiple ways. The first indicator was the discovery of conflicting data in deviation investigation reports, which led to confusion and…

Personnel not trained on revised SOP during audit – QMS remediation failure

During a routine FDA inspection at a mid-sized pharmaceutical manufacturing facility, inspectors detected a troubling pattern. Personnel involved in batch release processes were unable to appropriately reference the revised SOP…

Personnel not trained on revised SOP during deviation investigation – QMS remediation failure

The initial signals of inadequate training on a revised SOP manifest in multiple ways throughout the manufacturing and laboratory environment. In this case, deviations were observed during routine batch releases,…