The MHRA data integrity guidance is worth reading even for sites with no UK supply, because it defines each ALCOA+ attribute with practical expectations more clearly than most other published material.
MHRA is the UK regulator. Its guidance is not binding in the EU, but its data integrity material is widely used as a reference on the substance of the requirements.
Official sitePublished by MHRA. Verify current status at the source.
Defines each ALCOA+ attribute with worked expectations, and covers static versus dynamic records — the distinction behind the finding for retaining only a printout of a chromatogram.
Read the full articlePublished by MHRA. Verify current status at the source.
The UK position on GMP and GDP, including inspection and licensing arrangements.
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.