FDA Finalizes Comprehensive Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations
Public Comment Period for Revised Guideline on Quality Risk Management
Root Cause Investigation: The Foundation of Quality Problem Prevention
Changes in FDA Data Integrity Observations
Establishment of PIC/S GMP Annex 16: Critical Considerations for Batch Release Authorization
The Seven Steps of CAPA
Why Horizontal Deployment is Not Preventive Action: Understanding CAPA Fundamentals
Electronic vs. Paper Records: Which Is the True Record?