QA
Quality assurance and the system as a whole
“Who reviews audit trails, how often, and what did they find?”
An enabled but unreviewed audit trail provides no assurance and is straightforward for an inspector to test with one question.
Quality · Data integrity
Data integrity
Data integrity is the property that makes every other record meaningful, which is why its failures expand beyond the record where they were found.
In one line
Maturity here is the degree to which the compliant route is also the easy route.
Start hereEach step links to the next rather than dead-ending.
From understanding to action
01 · Understand
Reference article
The requirement, the failure modes and the primary sources.
02 · AssessGMP Health Index
Score this domain and see where it sits against the others.
03 · PositionMaturity model
What each level looks like, and what moves you up one.
04 · If it is urgentCrisis guidance
First actions, evidence to preserve and what not to do.
One GMP problem. Multiple perspectives.Roles that genuinely see this differently — not the same text with the job title changed.
Data integrity from five GMP roles
QC
Laboratory, testing and analytical data
“Are we retaining source data for dynamic records?”
A printed chromatogram loses the ability to reconstruct integration and reprocessing. The source file is the raw data.
Manufacturing
Production, process and the floor
“Are records made at the time, at the line?”
Recording on scrap paper and transcribing later breaks contemporaneity and originality simultaneously.
QP
Certification and batch release
“Can I rely on the data behind this certification?”
Where data integrity is in question, the evidential basis for release is in question with it.
Regulatory
Requirements, dossier and authority expectations
“What do PI 041 and the MHRA guidance actually require?”
Both set out ALCOA+ expectations across paper, hybrid and electronic systems, and are the appropriate reference for scoping a review.
Related
Reading, services and tools
Knowledge base
Where we do the work
People and training
Next step
Score it rather than estimate it
The GMP Health Index scores seven quality-system domains and maps each to a maturity level. It calculates in your browser and keeps history on your device only.