When performing manufacturing-related activities, regulated data and electronic records are produced and must be securely maintained or submitted with integrity as per the predicate rules. This book uses the data/e-records lifecycle process workflow as a reference to provide DI controls for managing the CGMP Data System in the medicinal manufacturing regulatory environment. The controls ensure compliance with drug regulations, including those for human drugs and biological products regulated by authorities, to maintain the integrity of the data/e-records. The book is comprised of sixteen...