2022.02.08 Part11 FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
Compliance with GMP ordinances 【Compliance with GMP ordinances】OOS/OOT Survey Rules and Procedures $500
Compliance with GMP ordinances 【Compliance with GMP ordinances】Collection of computerized system management procedures (SOPs) $3,000