ALCOA+ record check: test one record against all nine attributes
Pick one record, a balance printout, an HPLC result or a logbook entry, and answer one plain question per attribute. The check writes down what you found and what to fix for each, ready to print or copy. ALCOA is FDA’s list of five; the + is the four PIC/S lists. For the background, read the ALCOA+ principles guide.
The tool
Click any answer to change it. Pre-filled with a realistic example: a balance printout with two gaps.
ALCOA
The five attributes in FDA's 2018 data integrity Q&A
AttributableCan you tell from the record who made it, who changed it, and when?
A balance or pH meter that stores nothing cannot say who pressed print. The person has to sign and date the slip.
LegibleCould someone who was not there read it without asking, including the value under any correction?
ContemporaneousWas it recorded at the time the work was done, with a correct time on it?
The printout's time stamp comes from the instrument's own clock.
OriginalIs this the first capture of the data, or a verified true copy, kept in the form it was made?
For a balance or pH meter that stores nothing, the printout is the original record (FDA Q&A Q10).
AccurateDoes the record match what really happened, and has someone checked it against the source?
The four + attributes
Listed in PIC/S PI 041-1 (2021), which makes the list ALCOA+
CompleteIs everything there to recreate the event: every page and result, failed and repeat runs, and the metadata?
Every slip from the session counts, including weighings that were rejected.
ConsistentIs it recorded the same way as other records of its kind: date format, units, rounding, time order?
EnduringWill it last, intact and readable, for the whole retention period your predicate rule sets?
If the printer uses thermal paper, the slip will fade. PIC/S names thermal paper as a printout that fades.
AvailableCould you put it in front of a reviewer or an inspector, readable, on any day of the retention period?
ALCOA+ record check
- Record
- Analytical balance printout: sample weights for the assay of batch 24-117, taped into notebook QC-031
- Kind
- Instrument printout
- Checked by
- QC reviewer
- Date
- 2026-10-22
Result
2 gaps to fix
ALCOA, the 5 attributes in FDA's 2018 Q&A: 1 gap. The four attributes listed in PIC/S PI 041-1 for ALCOA+: 1 gap.
Fix first: Attributable, Enduring.
Attributable
Gap
ALCOA, FDA 2018
Nobody can be identified from the record as the person who made or changed it.
Fix: The analyst signs and dates the printout as it comes off the instrument and writes the sample ID and batch number on it (PIC/S PI 041-1 § 8.9.1). Then attach it to the test record.
Legible
Holds
ALCOA, FDA 2018
The record reads clearly and nothing is hidden by a correction.
Contemporaneous
Holds
ALCOA, FDA 2018
The record was made at the time of the work.
Original
Holds
ALCOA, FDA 2018
The original record, or a true copy of it, is what is kept.
Accurate
Holds
ALCOA, FDA 2018
The values are right and a second person has checked them.
Complete
Holds
+, PIC/S 2021
Everything needed to recreate the event is in the record.
Consistent
Holds
+, PIC/S 2021
The record follows the site's conventions and runs in time order.
Enduring
Gap
+, PIC/S 2021
The record will not survive the retention period in its current form.
Fix: Thermal printouts fade. Make a true copy now, signed and dated, and keep it with the original (PIC/S PI 041-1 § 8.6 and § 8.10).
Available
Holds
+, PIC/S 2021
The record can be produced on request and read.
ALCOA as listed in FDA’s Data Integrity and Compliance With Drug CGMP Q&A (2018); complete, consistent, enduring and available as listed in PIC/S PI 041-1 (2021). General information, not regulatory advice.
What it checks
ALCOA+ is a list of nine things a trustworthy record has to be. Five come from FDA’s 2018 data integrity Q&A. The PIC/S data integrity guide, PI 041-1 (2021), lists the same five and four more: complete, consistent, enduring and available. That longer list is ALCOA+.
FDA's 2018 wording
Data integrity is “the completeness, consistency, and accuracy of data”, and such data should be “attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”.
The check takes one record through all nine and writes down, for each, what you found and what to do about it. It is a working sheet for a reviewer or a QA lead, not a score. For the principles themselves, with a record that meets each one and one that does not, read the ALCOA+ principles of data integrity.
Common misreading
ALCOA+ is not an FDA term. FDA’s 2018 Q&A names the five ALCOA attributes and never writes ALCOA+; the four added attributes are listed in PIC/S PI 041-1. FDA does expect complete data in lab records (for drugs, § 211.194(a)), so the four are not optional in practice, but quote them to the right body.
How to use the check
- One record
- Pick a single record, not a system: one balance slip, one chromatogram, one logbook page. A LIMS can hold strong and weak records side by side.
- Its kind
- Say what kind of record it is. The same question has a different answer for a slip from a balance that stores nothing and for a file in a chromatography data system.
- As found
- Answer from the record in front of you, as an inspector would read it, not from what the SOP says should happen.
- Gaps first
- Close the gaps, then the weak points. Copy or print the sheet and file it with the deviation or the review it belongs to.
Records held in a computer system bring Part 11 with them. When the check finds a gap in attribution or in what happens to a changed value, look at the system’s trail next with the audit trail review checklist, and read what an audit trail has to capture. Signed results go through the signature manifestation check.
Worked example: three lab records
Scroll sideways for all three records
| Attribute | Balance printout | HPLC result | Logbook entry |
|---|---|---|---|
| AttributableFDA 2018 | Gap | Gap | Holds |
| LegibleFDA 2018 | Holds | Holds | Weak |
| ContemporaneousFDA 2018 | Holds | Holds | Gap |
| OriginalFDA 2018 | Holds | Holds | Holds |
| AccurateFDA 2018 | Holds | Weak | Holds |
| CompletePIC/S 2021 | Holds | Gap | Holds |
| ConsistentPIC/S 2021 | Holds | Holds | Weak |
| EnduringPIC/S 2021 | Gap | Holds | Holds |
| AvailablePIC/S 2021 | Holds | Holds | Holds |
| Result | 2 gaps to fix | 2 gaps, 1 weak point | 1 gap, 2 weak points |
Holds: the record meets the attribute as it stands. Weak: it probably meets it, but nothing on the record proves it. Gap: it does not, and needs fixing before anyone relies on the record.
The balance printout is the record the check opens with, and PIC/S PI 041-1 names both of its gaps. The slip came off a balance that stores no data, so the slip is the original record (FDA’s Q&A, question 10). Nobody signed or dated it, and it carries no sample ID: PIC/S PI 041-1 § 8.9.1 asks for exactly those on a direct printout, so Attributable is a gap. It is printed on thermal paper and taped into the notebook with no copy: PIC/S names thermal paper as a printout that fades and asks for a signed, dated true copy, so Enduring is a gap too. The weights are right and were reviewed, so the other seven hold.
The HPLC result fails differently. It was reprocessed under a shared lab login, which FDA’s Q&A says cannot be traced to one person, and only the final processed result was kept, which the same Q&A says is not acceptable for reprocessed chromatography. If your data lives in a spreadsheet instead, the questions about the original and about attribution are the hard ones; see Excel spreadsheets under Part 11.
Where the rule says so
FDA’s Q&A ties each ALCOA attribute to the drug CGMP sections that already require it; those cites are in the table as FDA lists them. The four + attributes have no such list, so their rows are our own mapping to the closest Part 11 control. For each control in full, read the Part 11 requirements section by section.
| Attribute | What it means | Where US rules ask for it |
|---|---|---|
| AttributableFDA 2018 | Who did the task and when, including who changed the record, when and why. | §§ 211.101(d), 211.122, 211.186, 211.188(b)(11), 212.50(c)(10); electronic: § 11.10(e) audit trail |
| LegibleFDA 2018 | Readable and unambiguous, including the original entries. | §§ 211.180(e), 212.110(b); electronic: § 11.10(e), changes do not obscure earlier data |
| ContemporaneousFDA 2018 | Recorded as the action or decision takes place. | §§ 211.100(b), 211.160(a); GLP: § 58.130(e), the person entering data identified at the time of input |
| Original or a true copyFDA 2018 | The first capture; data captured dynamically stays available dynamically. | §§ 211.180, 211.194(a); electronic: § 11.10(b) accurate and complete copies |
| AccurateFDA 2018 | A truthful representation of the facts, backed by qualified equipment, procedures and review. | §§ 211.22(a), 211.68, 211.188, 212.60(g); electronic: § 11.10(a) validation |
| CompletePIC/S 2021 | Nothing lost or deleted; for electronic data, the metadata too. | Our mapping: § 211.194(a), complete data from all tests; § 11.10(b) complete copies |
| ConsistentPIC/S 2021 | Created and stored in a defined, logical way: date formats, units, rounding, sequence. | Our mapping: § 11.10(f) checks that enforce the permitted sequence of steps |
| EnduringPIC/S 2021 | Intact and indelible for the whole retention period. | Our mapping: § 11.10(c) protection through the retention period, which the predicate rule sets (e.g. § 211.180, § 58.195) |
| AvailablePIC/S 2021 | Reviewable at any time in the retention period, by everyone who has to review it. | Our mapping: § 11.10(c) ready retrieval; § 11.1(e) systems open to FDA inspection |
Part 11 sets no retention period of its own; the predicate rule does. If you are not sure whether a record falls under Part 11 at all, run the Part 11 applicability checker first. Systems sold for this job are compared in data integrity software for GxP labs, and the systems that record storage temperatures for you in Part 11 temperature monitoring systems.
Sources
- Data Integrity and Compliance With Drug CGMP: Questions and Answers (December 2018, PDF), U.S. Food and Drug Administrationread 2026-10-22
- PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (1 July 2021, PDF), PIC/Sread 2026-10-22
- 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
- 21 CFR Part 211, CGMP for Finished Pharmaceuticals, eCFRread 2026-10-22
- 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, eCFRread 2026-10-22