The data integrity library of the GMP Training Academy
dataintegritytraining.com is one of a family of topic sites run by The GMP Training Academy, an initiative of Truex Consultancy B.V. in Amersfoort, the Netherlands. Each one goes deep on a single part of the quality system and points to the course that teaches it.
Because data integrity deserves more than a course page
Most GMP training sells a course and stops. We wanted a place where the free material is genuinely useful on its own: guides you can use in tomorrow's record review, a checklist QA can run today, and a findings library that shows what actually gets cited. If that is all you take from here, good. If you want the full method with practice and a certificate, the course is on the academy.
Four rules
If it would not hold up in an inspection, it is not here
Every practice on this site is one we would defend in the room. Where the regulation is silent we say so, and where sites commonly get away with less, we still teach the defensible version.
Regulation quoted, not paraphrased
Each guide and glossary term cites the clause. You should be able to take any statement here to your QA head with the reference attached.
Written from findings, not from slides
The course and the guides start from what regulators actually cite in data integrity inspections and work back to the practice that would have prevented it.
One system, not a silo
Data integrity is not an IT topic. It runs through batch records, laboratory systems, training, validation, deviations and management review. The course teaches the connections because that is how inspectors read the records.
One academy, one certificate standard, many topics
The GMP Training Academy runs courses on deviation management, change control, CAPA, data integrity, product quality review, management review and more. Every course uses the same assessment and certificate standard, so a training matrix built on academy certificates is consistent.
From what regulators cite, not from a syllabus
The course was not written from a syllabus. It was written from what regulators publish about how records fail, then worked back to the practice that would have kept them true.
- 1Start from the deficiency category, not the regulation
- 2Find the practice that would have prevented the finding
- 3Tie that practice to its clause so it can be defended in the room
- 4Teach it on a real record, then test it
EMA questions and answers on data integrity (GMP/GDP Inspectors Working Group)
The definitions of raw data, true copy and audit trail review that the course uses, framed the way EU inspectors apply Chapter 4 and Annex 11 on site, and the expectations on data governance that Module 6 is built on.
PIC/S PI 041-1 Good Practices for Data Management and Integrity
The inspector's own guidance: how data integrity is assessed on inspection, system by system, with the specific vulnerabilities inspectors are told to look for.
EudraGMDP non-compliance statements and EMA inspection findings
Published statements of non-compliance and the deficiency analyses that EU national competent authorities release. Data integrity, documentation and computerised systems are consistently among the most cited categories.
National competent authority inspection reports and ICH Q9 (R1)
Public deficiency summaries from EU national authorities citing Chapter 4 and Annex 11 sections 9 and 12, and the risk-based approach to data criticality and audit trail review that ICH Q9 (R1), adopted in the EU, underpins.
Site records reviewed in consultancy and audits
Anonymised logbooks, batch records, audit trails and spreadsheets, used to build the practice records and the weak-versus-defensible examples.
- Sources are public regulatory publications and anonymised records. The GMP Training Academy is not affiliated with or endorsed by any regulator.