Data integrity: complete, attributable records you can defend
Inspectors want to see who did what, when and why, in the original record. Here is what FDA's guidance asks, in plain words.
In Short
- FDA's data integrity Q&A is final, nonbinding guidance.
- ALCOA: attributable, legible, contemporaneous, original, accurate.
- Review audit trails before data drives a release.
Electronic Records & Inspection Readiness Buyer Guide
For quality, regulatory, validation and IT teams evaluating electronic records, signatures and inspection readiness. Use it with or without V5.
- See what a signature must show.
- Check corrections keep the original.
- Know where Part 11 applies.
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
Electronic Records & Inspection Readiness Buyer Guide
For quality, regulatory, validation and IT teams evaluating electronic records, signatures and inspection readiness. Use it with or without V5.
FDA's final guidance Data Integrity and Compliance With Drug CGMP explains how existing drug CGMP rules apply to data. ISPE's GAMP Guide: Records and Data Integrity (published March 2017, 152 pages) is a paid industry guide; we did not reproduce its content. This page uses the public FDA source. Sources were checked on 2 Oct 2026.
Law, Guidance and Industry Practice
The binding requirements are the CGMP rules themselves, such as 21 CFR Parts 211 and 11. FDA's Q&A is nonbinding guidance on applying them.
Which source is which
- Law21 CFR Parts 211 and 11Binding
The requirements
- GuidanceFDA Data Integrity and Compliance With Drug CGMP Q&AFinal, nonbinding
How FDA applies the rules to data
- VoluntaryISPE GAMP Guide: Records and Data IntegrityPaid industry guide (March 2017)
Practice detail; check your licensed copy
More on law, Guidance and Industry Practice
The ISPE GAMP guide is voluntary industry practice; check your licensed copy for its detail.
ALCOA in Plain Words
FDA describes data as attributable, legible, contemporaneously recorded, original or a true copy, and accurate. In practice: you can tell who did it and when, you can read it, it was written at the time, you know which is the original, and it is right.
Audit Trails and Review
Audit trails record who created, changed or deleted data and why. A trail nobody reviews protects little; set review by risk, so data that affects batch decisions is reviewed before release.
Worked Example: an Audit Trail Review Before Release
- Batch endReviewer opens audit trail for batch L-0390 resultsQA reviewer
- +10 minOne result re-entered with reason 'typo'; original value retainedQA reviewer
- +30 minAnalyst and raw data confirm the correctionLab supervisor
- +1 hReview signed; batch goes on to dispositionQA reviewer
Where V5 fits
V5 records an audit trail, Part 11 electronic signatures and role-based access. Your team sets procedures, reviews audit trails and decides on data and batches.
More on where V5 fits
Enterprise includes IQ/OQ and validation support; your team validates for intended use.
Questions
Is FDA's data integrity guidance binding?
No. It is final, nonbinding guidance explaining how existing drug CGMP regulations apply. The regulations themselves are binding.
Is the ISPE GAMP Records and Data Integrity guide free?
No. ISPE sells it, with member and non-member prices. We have not reproduced its content.
What does ALCOA stand for?
Attributable, legible, contemporaneous, original or a true copy, and accurate.
Does V5 make our data compliant?
No software makes a site compliant. V5 provides audit trails, electronic signatures and access controls; your procedures, reviews and validation decide whether the controls are adequate.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
