What is critical thinking?
Is potato chip a more high-tech product than pharmaceuticals?
Is Security and Audit Trails Enough for Data Integrity?
Part 11 History and Trends
Open Systems
Issues related to long-term preservation of electronic records
FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
Part11査察の再開
真正性の要件