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。 1. Please clarify the following 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 usetheterms “static” and “dynamic” asthey relate to record formats? e. How does FDA use the term “backup” in § 211.68(b)? f.What arethe “systems”in “computeror related systems”in § 211.68? 2. When is it permissible to exclude CGMP data from decision making? 3. Does eachworkflow on our computer system need to be validated? 4. How should access to CG