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
出荷判定のあり方について