The Relationship Between CSV, Qualification, and Process Validation
Classification and Validation of Computerized Systems Used in GMP
Software Category Classification: Focus on User Requirements, Not Labels
Internal Audits: Understanding Their True Purpose
Software Categorization in Pharmaceutical Manufacturing
Review and Approval: Understanding the True Meaning and Current Practices
About FDA Form 483
Preventive Action as Risk Management: Understanding CAPA in Pharmaceutical and Medical Device Industries