解读FDA数据完整性和cGMP合规指南.pdfVIP

FDA 于2016年4 月发布数据完整性和cGMP合规指南。FDA 以18个问 题和回答澄清cGMP 的数据完整性。中文翻译来自Chengks。 1. Please clarify thefollowing terms as they relate to CGMP records: a.What is “data integrity”? b.What is “metadata”? c.What is an“audit trail”? d. How does FDA use the terms “static” and “dynamic” as they relate to recordformats? e. How does FDA use the term “backup” in§ 211.68(b)? f.What are the “systems” in“computeror related systems” in § 211.68? 2.When is it permissible to exclude CGMPdatafromdecision making? 3. Does eachworkflow onour computersystem need