Part11

2026.01.16

What You Can’t Ask Now: Part 11 Edition

2026.01.16

The Three Requirements for Authenticity in Electronic Records

2023.11.18

Are You Confusing Part 11 with Data Integrity? Understanding the Critical Distinction

2023.06.17

What is critical thinking?

2023.06.10

Is potato chip a more high-tech product than pharmaceuticals?

2023.03.20

Is Security and Audit Trails Enough for Data Integrity?

2023.03.09

Part 11 History and Trends

2023.02.24

Open Systems

2023.02.20

Issues related to long-term preservation of electronic records

2022.02.08

FDA CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」