PIC/S GMP Annex 16 newly established
Fewer data integrity findings
Determine the root cause
Public comments on proposed amendments to ICH Q9 QRM
品質リスクマネジメントに関するガイドラインの改正（案）に対するパブリックコメントの募集
FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
FDA Plans to Issue Part 11 Q&A Guidance
FDA U.S. inspections resumed
When is a manufacturing and marketing license required to be obtained?