Data Lifecycle and Data Integrity

ISBN-13: 9798891134621 / Angielski / Twarda / 2024

Orlando López

Opis

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 chapters and seven appendices addressing the production and quality control systems in medicine manufacturing environments. It provides a comprehensive guide to maintaining the integrity of data and electronic records by CGMP Data Systems' drug regulations.