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Audit Trail Review Procedures: What FDA Expects and How to Build a Compliant Process
Why audit trail review is a recurring FDA inspection finding FDA inspectors consistently cite audit trail deficiencies as some of
Risk-Based Approach to Computer System Validation: Applying FDA’s CSA Framework in Practice
For decades, pharmaceutical and medical device companies validated computer systems using a documentation-heavy approach rooted in traditional IQ/OQ/PQ protocols. For
21 CFR Part 11 Compliance Checklist: Electronic Records and Electronic Signatures
21 CFR Part 11 is the FDA regulation that defines the conditions under which electronic records and electronic signatures are
Medical Device PMA (Premarket Approval) Quality Requirements: What FDA Expects
Premarket Approval (PMA) is the most demanding regulatory pathway for medical devices in the United States. Class III devices, those
Pharma Contract Manufacturing Organization (CMO) Quality: Managing Quality When You Don’t Own Manufacturing
Pharmaceutical companies that outsource manufacturing to contract manufacturing organizations (CMOs) face a compliance problem that is easy to misunderstand: FDA
Medical Device 510(k) Submission: QMS Requirements and Design Control Documentation
A 510(k) premarket notification clears a medical device for commercial distribution in the United States by demonstrating substantial equivalence to