Is Computer System Validation Required for All Computer Systems?
Why Pre-Sterilization Cleaning and Drying Are Necessary
The Importance of Fast Time to Market in Pharmaceutical Development
Differences in Regulatory Requirements Between Western Countries and Japan
The Three Requirements for Authenticity in Electronic Records
Issuance of Administrative Notice on Manufacturing and Quality Management Systems for Pharmaceutical Manufacturers
FDA Inspection Activities: Historical Context and Current Status
Why FDA GMP Inspections of Japan Continue: A Comprehensive Analysis