FDA Data Integrity Guidance · ALCOA+
ALCOA+ applied to preventive
maintenance documentation
ALCOA+ is not a documentation style guide. It is the framework FDA investigators apply during inspections to determine whether your data can be trusted. Every PM record is measured against it. Attributable, Legible, Contemporaneous, Original, Accurate, and the four additions: Complete, Consistent, Enduring, Available. A record that fails any one of these is a potential data integrity observation.
Preventive maintenance records fail ALCOA+ more consistently than almost any other GMP document, because most PM records are designed for task completion, not evidence. This page maps each principle to the specific element of an execution record it requires, and shows what a record that satisfies all nine looks like.
What ALCOA+ requires for PM records
FDA Data Integrity Guidance · 2018"Data integrity is fundamental to a pharmaceutical quality system ensuring that medicines are of the required quality. Complete, consistent and accurate data should be attributable, legible, contemporaneous, original and accurate."
FDA Guidance: Data Integrity and Compliance With Drug CGMP ↗
A: Attributable
Who performed each step, and when. A single completion signature does not cover individual steps.
L: Legible
Permanent and readable. Handwritten logs with strike-throughs and corrections without initials fail this.
C: Contemporaneous
Recorded at the time of execution. The most common failure mode in PM records.
O: Original
The first record of the data. Transcriptions and retyped paper logs are copies, not originals.
A: Accurate
Reflects what actually happened. Corrections must be visible, dated, initialed, and explained.
+ Complete, Consistent, Enduring, Available
All required steps present. Internally coherent sequence. Durable and unalterable. Retrievable on request.
Where PM records fail ALCOA+
A data integrity observation under ALCOA+ is distinct from a § 211.67 documentation finding. It does not just say "your record is incomplete." It says "your data cannot be trusted." That distinction changes the scope of the corrective action significantly. The FDA expects a systemic fix, not a retraining memo.
The three failure patterns below are the most common ALCOA+ gaps in preventive maintenance records. Each one is structural, it cannot be fixed by asking technicians to be more careful.
Not contemporaneous
PM log completed at shift end. Individual step timestamps absent or identical. The record cannot prove steps happened in the order documented.
Not attributable
One technician signature covers the entire work order. Steps performed cannot be individually attributed. Fails A before C is even examined.
Not original
Paper checklist photographed and retyped into the electronic system. The e-record is a copy. The original paper record is the data, and it has been discarded.
What a record that satisfies ALCOA+ looks like
Each ALCOA+ principle maps to a structural feature of the bundle.
The record below is a .pruved bundle. It satisfies ALCOA+ not through policy, but through how it is built. Attribution is embedded at the step level. Timestamps are generated by the system at execution. The bundle is sealed at sign-off and cannot be edited after the fact. The export is always retrievable.
ALCOA+ · A
Attributable
EMP-0318 · each step
ALCOA+ · C
Contemporaneous
09:14 · 09:19 · 09:24 · 09:28
ALCOA+ · O + E
Original + Enduring
Bundle sealed at sign-off
ALCOA+ · + C
Complete + Consistent
All SOP steps present
Closing a data integrity observation
A data integrity observation tied to ALCOA+ is harder to close than a standard documentation finding, because the root cause is structural. You cannot fix "not contemporaneous" by retraining technicians to fill in logs faster. The FDA expects evidence that the record system itself captures data at the point of action, not that staff have been reminded to do so.
The .pruved bundle is structured around ALCOA+ by design. Timestamps are generated by the system at the moment of execution, they cannot be entered or altered by the user. Attribution is captured per step, not at task completion. Sealing at sign-off satisfies Original and Enduring simultaneously. The export is always retrievable for inspection, satisfying Available. When an investigator applies ALCOA+ to a .pruved record, every principle maps to a structural feature of the bundle, not to a policy or a training record.
If the data integrity concern surfaced through a § 211.67 observation, the record shown above is the exhibit your CAPA response needs. The same record that satisfies data integrity also satisfies the documentation requirements of § 211.67 and § 211.182.
Data integrity observations do not close with a procedure update
They close with a record that was right from the start.
In 30 minutes we will show you how each ALCOA+ principle maps to a specific field in a Pruved bundle, and walk through exactly what your inspector would see when reviewing the record.
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