Why data integrity matters
A batch is released on the strength of its records. If those records cannot be trusted - a result entered later and back-dated, a deleted injection, a shared login - the batch cannot be trusted either. Data integrity failures have been among the most frequent observations in regulatory inspections of pharmaceutical plants for more than a decade, and they can lead to warning letters, import alerts and recalls.
What ALCOA+ means, letter by letter
- Attributable
- Every entry shows who made it. That rules out shared accounts: each person signs in as themselves.
- Legible
- The record can be read and understood for as long as it is kept - including its history of changes.
- Contemporaneous
- It is recorded when the work is done, with a time the user cannot set themselves.
- Original
- The first capture (or a verified true copy) is kept. A correction never overwrites what was there.
- Accurate
- It is correct and checked - by rules in the system and, where it matters, by a second person.
- Complete, Consistent, Enduring, Available
- Nothing is missing, events are in order, records survive for the retention period, and they can be retrieved for review or inspection.
What the regulators expect
The principles are the same across the major guidances, which are worth reading in full:
- US FDA - Data Integrity and Compliance With Drug CGMP: Questions and Answers (guidance for industry, December 2018).
- UK MHRA - 'GXP' Data Integrity Guidance and Definitions (March 2018).
- WHO - Guideline on data integrity, Technical Report Series No. 1033, Annex 4 (2021).
- PIC/S - Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PI 041-1 (2021).
For computerised systems specifically, 21 CFR Part 11 (United States) and EU GMP Annex 11 set out the controls for electronic records and signatures - see our article on 21 CFR Part 11 in practice.
How software supports ALCOA+
Paper can meet ALCOA+, but it relies on discipline. A well-designed system builds the controls into the work, so the right way is also the only way:
- Personal logins and role-based access make every entry attributable and limit who can do what.
- Server timestamps make entries contemporaneous - the user's clock is never used.
- Append-only audit trails keep the original and every change: who, when, from what, to what, and why.
- Electronic signatures record the person, the time and the meaning of the signature (reviewed, approved, released).
- Two-person rules - the author cannot approve their own record - catch errors before they matter.
- Rules that stop wrong steps - an unapproved lot cannot be issued, an open deviation blocks release - keep records consistent with what actually happened.
- Backups with tested restores make records enduring and available.
Common gaps to look for
- Shared or generic accounts on instruments and systems.
- Corrections without a reason, or that overwrite the original value.
- Audit trails that exist but are never reviewed.
- Spreadsheets used for GMP calculations without control.
- Printouts treated as the record while the electronic original is lost.
This article is general information, not regulatory advice. Compliance depends on how a system is validated and used at your site.