Data Integrity Checker

Some words in a record make an inspector stop and ask for the audit trail. Backdated. Test injection. Shared login. Reprocessed. Paste a record, investigation or audit trail export and the Data Integrity Checker marks each one with the ALCOA+ principle at stake.

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78 words8 data integrity red flags2 cfr citations

Deviation DEV-2026-031 (example) During HPLC assay of batch 26-118, two test injections were run before the system suitability sequence and were deleted. The analyst used the shared login on the instrument PC. The result was reprocessed with manual integration and the first run was invalidated. Weights were written on scrap paper and transcribed into the batch record the next day, which was backdated to the date of weighing. QA reviewed the investigation under 21 CFR 211.192 and 211.194(a).

Flagged, and what to write instead

deletedComplete: Was the deletion authorized and audit-trailed?
shared loginAttributable: Actions cannot be attributed to one person.
reprocessedAccurate: Reprocessing needs a documented, approved reason.
manual integrationAccurate: Needs a procedure, a reason and second-person review.
invalidatedAccurate: Invalidation needs a scientifically justified root cause.
scrap paperOriginal: Uncontrolled record.
transcribedOriginal: Data copied from another record; is the original kept?
backdatedContemporaneous: Entry dated earlier than it was made.
21 CFR 211.19221 CFR 211.192: cited at 296 of 774 Part 211 drug inspections (38.2%).
211.194(a)CFR citation.

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How to use the Data Integrity Checker

Step 1
Paste a record, deviation, investigation or audit trail export. The example is a made-up HPLC deviation with eight problems.
Step 2
Read each red flag and the ALCOA+ principle it touches.
Step 3
Pull the audit trail or justification for every flagged entry, then save the review.

What the Data Integrity Checker flags

The words inspectors notice first

Backdated, pre-signed, scrap paper, overwritten, orphan data and 35 more, each tied to the ALCOA+ principle at risk.

Built for chromatography and LIMS review

Trial injections, reprocessing, manual integration, aborted runs and invalidated results get their own flags.

The CFR sections behind the finding

Shows 211.68(b), 211.194 and the other sections in your text, with how often FDA cites them.

Your document stays on your computer

The check runs in your browser tab. No upload, no copy on a server, and no analytics on the text box.

Opens Word files

Drop in a .docx, .txt or .md file, or paste from a PDF or your document system. Word files are unzipped and read locally.

Free, no account

Use it as often as you like. We only ask for an email if you want to save the review as a PDF.

What counts as a data integrity red flag?

A word or practice that suggests you cannot fully trust a record. Maybe someone else signed it, or the entry came days later, or the original was copied and thrown away, or a result was run three times and only the passing one survived.

ALCOA+ gives the checklist: attributable, legible, contemporaneous, original, accurate, then complete, consistent, enduring and available. Inspectors from FDA, MHRA and WHO look for these words in lab records, audit trails and investigations.

Which data integrity terms does the checker flag?

Treat each flag as a prompt to look closer. A deletion that was authorized, justified and audit-trailed is fine; the same word with no paper trail turns into a Form 483 observation.

Term	Why it matters	ALCOA+ principle
backdated	Entry dated earlier than it was made.	Contemporaneous
back-dated	Entry dated earlier than it was made.	Contemporaneous
pre-dated	Entry dated before the activity.	Contemporaneous
post-dated	Entry dated after the activity.	Contemporaneous
pre-signed	Signature before the work was done.	Attributable
signed on behalf	Signature by someone other than the doer.	Attributable
recreated	Record rebuilt after the fact.	Original
re-created	Record rebuilt after the fact.	Original
rewritten	Original replaced by a new copy.	Original
transcribed	Data copied from another record; is the original kept?	Original
transcription	Copying step; check the original is retained and verified.	Original
scrap paper	Uncontrolled record.	Original
sticky note	Uncontrolled record.	Original
loose sheet	Uncontrolled record.	Original
uncontrolled form	Record outside document control.	Original
unofficial	Data held outside the official record.	Complete
white-out	Obscured entry.	Legible
correction fluid	Obscured entry.	Legible
obliterated	Original entry no longer readable.	Legible
overwritten	Original value lost.	Original
deleted	Was the deletion authorized and audit-trailed?	Complete
discarded	Was the data reviewed before it was discarded?	Complete
trial injection	Unreported injections are a classic 483 finding.	Complete
test injection	Unreported injections are a classic 483 finding.	Complete
pre-injection	Check it is part of the reported sequence.	Complete
re-injected	Retesting into compliance? Check the justification.	Accurate
reinjected	Retesting into compliance? Check the justification.	Accurate
reprocessed	Reprocessing needs a documented, approved reason.	Accurate
reintegrated	Reintegration needs a documented, approved reason.	Accurate
manual integration	Needs a procedure, a reason and second-person review.	Accurate
aborted run	Aborted sequences must be reviewed and reported.	Complete
invalidated	Invalidation needs a scientifically justified root cause.	Accurate
orphan data	Data not linked to a reported result.	Complete
shared login	Actions cannot be attributed to one person.	Attributable
shared password	Actions cannot be attributed to one person.	Attributable
generic account	Actions cannot be attributed to one person.	Attributable
admin rights	Can the user who generates data also delete it?	Attributable
audit trail disabled	No record of who changed what.	Enduring
audit trail off	No record of who changed what.	Enduring
not contemporaneous	Recorded after the fact.	Contemporaneous

How does FDA cite data integrity problems?

Mostly through the predicate rules. Computer controls go under 211.68(b), lab records under 211.194, batch records under 211.188 and investigations under 211.192. In the Atlas Form 483 dataset (January 2025 to October 2026), 211.68(b) or 211.194 appeared at 196 of 774 drug inspections citing Part 211. Part 11 itself came up at 3 inspections out of 7,377.

Does my document get uploaded?

No. Your browser does all the work. The text you paste and the file you open stay on your computer, the checker reads them in memory, and closing the tab wipes them. Atlas never receives a word of it.

We also switched off session recording and analytics on the tool itself, so nothing you type reaches a tracking script. You can check this yourself: open the network tab in your browser's developer tools, run a check, and watch nothing leave. Your company's rules on where confidential documents can be opened still apply.

Frequently asked questions

What does ALCOA+ stand for?

Attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available. Regulators use the list to judge whether GMP data, on paper or in a system, can be trusted from creation to archive.

What is a data integrity checklist?

A list of what to verify in a GMP record or system: unique logins, audit trails switched on and reviewed, entries made at the time, originals kept, corrections done properly, and every result reported. This checker covers the record wording. System controls need their own assessment.

What are common data integrity findings?

Shared logins, audit trails switched off or never reviewed, unreported trial injections, deleted or overwritten data, backdated or pre-signed entries, data on scrap paper, and results invalidated without a real root cause.

Is a test injection always a violation?

No. Test or trial injections must follow a procedure, be kept, and be reviewed with the reported data. Injecting to preview a result and then deleting it is one of the most cited data integrity findings in FDA warning letters.

Can I check an audit trail export?

Yes. Paste the text of the audit trail report and the checker flags deleted, reprocessed, reintegrated, aborted and similar entries. Then match each one to its reason for change.

Does this check Part 11 compliance?

No. Part 11 depends on system controls like access, audit trails, e-signatures and validation, which no text check can see. The checker finds words in records that point at a problem worth investigating.

What are the ALCOA principles in pharma?

They are the minimum standard for GMP data. Attributable means you know who did it. Legible means you can read it. Contemporaneous means recorded at the time. Original means the first capture, or a certified copy. Accurate means correct and complete.

Is my record sent to Atlas?

No. The check runs in your browser and nothing leaves your computer. Analytics and session recording are switched off on the tool.

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