Understanding Quality Assurance (QA): The Importance of Process Quality Assurance
The Evolution of Electronic Records Regulations: From FDA Part 11’s Tumultuous Past to Today’s Global Harmonization
Correct Understanding of Electronic Signatures under 21 CFR Part 11
Risk-Based Approach in FDA Regulations: A Modern Framework for Computer System Validation
CSV and Quality Assurance (Revised Edition)
Understanding Assurance in Computer System Validation (CSV)
The Relationship Between URS (User Requirements Specification) and PQ (Performance Qualification)
Understanding Authenticity: A Core Requirement of Japanese ER/ES Guidelines