Understanding “Storage” in Japanese ER/ES Guidelines: A Critical Concept Often Misunderstood
What is the Electronic Document Law?
Understanding Electronic Signatures: A Comprehensive Guide
Electronic Documents Requiring Electronic Signatures: Understanding FDA Part 11 and Japan’s ER/ES Guidelines
Challenges in Electronic Record Retention Requirements: Maintaining Authenticity During Long-term Preservation and System Migration
Commentary on GAMP 5: Evolution and Current State
Outlook for Part 11 Revision: Historical Context and Current Status
Analysis of EU GMP Annex 11 Revision: The Significance of the 2025 Draft and Future Outlook