Warning Letter on CSV/Part 11
Is CSV implementation that important?
How to establish a QMS
Fewer data integrity findings
FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
Three requirements for authenticity
Do all computer systems require CSV?
PIC/Sデータインテグリティガイダンス発効（その3）
FDAの海外査察の状況