PIC/S alignment is why the EU text travels. A PIC/S-participating inspectorate outside the EU largely recognises the same structure and expectations.
PIC/S is a co-operative arrangement between inspectorates. It is not a regulator and issues no authorisations; its guidance is adopted by participating authorities.
Official sitePublished by PIC/S. Verify current status at the source.
The most detailed public treatment of data governance expectations across paper, hybrid and electronic systems. Read alongside the MHRA guidance, which defines the ALCOA+ attributes.
Read the full articlePublished by PIC/S. Verify current status at the source.
The PIC/S GMP Guide and the aide-mémoires inspectors use. The aide-mémoires are particularly useful for understanding how a topic is actually examined.
GMPConsultant.nl is an independent advisory. It is not a regulator, a notified body or a certification body. Explanations on these pages are our interpretation, published separately from the official text so the two are never confused. Always verify against the primary source before acting — guidance is revised, and a page here may not reflect the most recent position.
Knowing what a source says is the start. The Health Index turns it into a scored position across seven domains, and the knowledge base explains where each requirement goes wrong in practice.