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CAPA After the Audit: Closing Findings So They Stay Closed
An audit finding is cheap. What it costs is determined entirely by what happens next. Inspectors across GMP, GDP, pharmacovigilance and medical device frameworks pay[…]
Auditing the Regulatory Affairs Function: The Compliance Area Nobody Audits
Manufacturing is audited. Laboratories are audited. Pharmacovigilance is audited because the law requires it. Regulatory affairs — the function that owns the dossier, the commitments,[…]
Self-Inspection Under EU GMP Chapter 9: The Audit You Run on Yourself
Chapter 9 of the EU GMP Guide is one of the shortest chapters in the guide and one of the most revealing. Self-inspection is the[…]
Auditing Cosmetics Compliance: ISO 22716, the Product Information File and the Responsible Person
Cosmetics are not authorised before they reach the EU market, and that absence of a pre-approval step misleads people about how regulated the sector actually[…]
Auditing a Medical Device Quality System: ISO 13485, MDR Surveillance and the New QMSR
A medical device manufacturer selling into Europe and the United States is now audited against a quality system standard that both jurisdictions recognise. Since 2[…]
Building a Risk-Based Pharmacovigilance Audit Programme
Auditing your pharmacovigilance system is not optional and not a quality-department formality. It is a legal obligation on the marketing authorisation holder, its results are[…]
Validating Cloud and SaaS GxP Systems: Supplier Oversight and Shared Responsibility
Most regulated companies now run at least one GxP-critical process on software they do not host, cannot inspect directly, and cannot stop from updating. That[…]
Data Integrity and ALCOA+: Turning Audit Trail Review into a Real Control
Data integrity findings rarely arise because a company set out to falsify anything. They arise because nobody was looking. A system generates an audit trail,[…]
Computer Software Assurance: What FDA’s Final CSA Guidance Changes
For two decades, validating software used in production and quality systems meant generating documentation — often a great deal of it, and often with little[…]
Computerised System Validation: A Risk-Based Lifecycle That Survives Inspection
Almost every GxP decision a company makes today rests on data produced, stored or transformed by a computerised system. Regulators have responded by treating those[…]