GxP Document Checker

Paste an SOP, batch record, deviation or audit report. In a second you see what an auditor would circle in red: vague steps, data integrity red flags, missing sections and every 21 CFR reference. It all happens in your browser.

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Opens .docx

Open .docx, .txt or .mdStays on your computer.

82 words7 vague language1 data integrity red flags2 cfr citations

SOP-QA-014 Cleaning of Granulation Equipment Purpose: To describe the cleaning of the high shear granulator. Scope: Applies to the granulation suite. Procedure: 1. The operator should clean the bowl as appropriate after each campaign. 2. Rinse with purified water periodically and dry the bowl adequately. 3. Swab samples are taken if necessary and sent to QC in a timely manner. 4. Record results on the log sheet. Transcribed values are reviewed by QA, etc. Reference: 21 CFR 211.67 and 21 CFR 211.100(a).

Flagged, and what to write instead

shouldUse "must" or "shall" for a requirement; "should" reads as optional.
as appropriateWho decides what is appropriate? State the condition.
periodicallyGive a frequency: daily, each batch, every 6 months.
adequatelyGive the acceptance criterion.
if necessaryName the condition, or the step is optional.
in a timely mannerGive a deadline, such as 30 calendar days.
TranscribedOriginal: Data copied from another record; is the original kept?
etc.An open list cannot be followed or audited. List every item.
21 CFR 211.6721 CFR 211.67: cited at 244 Part 211 drug inspections.
21 CFR 211.100(a)21 CFR 211.100: cited at 224 Part 211 drug inspections.

Sections this SOP is missing

Responsibilities, Definitions or abbreviations, Training, Revision or change history, Approval signatures, Effective date

We receive your email and nothing else. Your browser builds the PDF from text that never leaves it.

How to use the GxP Document Checker

Step 1
Paste your text, or open the .docx. The example below is a deliberately sloppy SOP.
Step 2
Switch checks on or off: vague wording, data integrity, CFR citations, your own word list.
Step 3
Hover any highlight to see why it was flagged, fix the wording, and save the review as a PDF.

What the GxP Document Checker catches

Steps an operator could read two ways

40 words like "as appropriate", "periodically" and "should", each paired with the fix: a number, a trigger or a named role.

Words that hint at a data integrity problem

40 terms such as backdated, test injection and shared login, tagged with the ALCOA+ principle each one puts at risk.

Every 21 CFR reference

Parts 11, 210, 211, 820, 803 and more. For Part 211 sections you also see how often FDA cited them on recent Form 483s.

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.

Which documents can you check?

Anything a quality reviewer reads before signing. SOPs and work instructions, batch manufacturing and packaging records, logbooks, lab notebooks, deviation and OOS investigations, CAPA plans, change controls, validation protocols, audit reports, even your draft response to a Form 483.

A procedure and a record fail in different ways. A procedure fails when two people can follow it differently. A record fails when you cannot tell who did what, when, and whether anything was thrown away. The checker looks for both.

Why does FDA care about the word "periodically"?

Because an investigator will read your SOP back to you and ask how often periodically is. If the answer lives in someone's head, the procedure is incomplete, and FDA writes that up under 21 CFR 211.100(a) for production steps or 211.22(d) for the quality unit's own procedures.

That second section leads the list. In the Atlas Form 483 citation dataset, investigators cited 211.22 at 352 of 774 drug inspections that touched Part 211 between January 2025 and September 2026. These are the words the checker flags, and what to write instead:

Word or phrase	Why it gets flagged
as appropriate	Who decides what is appropriate? State the condition.
as needed	Define the trigger that makes it needed.
as necessary	Define the trigger that makes it necessary.
if necessary	Name the condition, or the step is optional.
if required	Say what requires it.
where applicable	List where it applies.
when applicable	List when it applies.
if applicable	List when it applies.
periodically	Give a frequency: daily, each batch, every 6 months.
regularly	Give a frequency.
routinely	Give a frequency.
frequently	Give a frequency.
occasionally	Give a frequency or a trigger.
in a timely manner	Give a deadline, such as 30 calendar days.
timely	Give a deadline.
promptly	Give a deadline.
as soon as possible	Give a deadline.
adequate	Give the acceptance criterion that makes it adequate.
adequately	Give the acceptance criterion.
sufficient	Give the number or limit.
appropriate	Name the specific method, form or person.
properly	Describe the correct way, step by step.
suitable	Name the specification that makes it suitable.
reasonable	Give the limit.
approximately	Give a range with limits, such as 20 to 25 °C.
etc.	An open list cannot be followed or audited. List every item.
and/or	Say which: both, either, or one of them.
should	Use "must" or "shall" for a requirement; "should" reads as optional.
may	Optional wording in a GMP step. Use "must" if it is required.
could	Optional wording. State what is required.
normally	Say what happens in the abnormal case too.
usually	Say what happens when it is not usual.
typically	State the requirement, not the habit.
generally	State the requirement and its exceptions.
where possible	Say what to do when it is not possible.
if possible	Say what to do when it is not possible.
try to	A GMP step is done or not done. Remove "try to".
responsible person	Name the role, such as QA Manager.
TBD	An approved document cannot contain open items.
to be determined	An approved document cannot contain open items.

Which sections should a GMP SOP have?

The checker looks for each of these as a heading or a label and tells you which ones it could not find. A short work instruction can skip a few. A controlled SOP without named responsibilities, records or an approval block is an easy audit finding.

SOP section	Check
Purpose or objective	Flagged when no heading or label for it is found.
Scope	Flagged when no heading or label for it is found.
Responsibilities	Flagged when no heading or label for it is found.
Definitions or abbreviations	Flagged when no heading or label for it is found.
Procedure	Flagged when no heading or label for it is found.
References	Flagged when no heading or label for it is found.
Records or documentation	Flagged when no heading or label for it is found.
Training	Flagged when no heading or label for it is found.
Revision or change history	Flagged when no heading or label for it is found.
Approval signatures	Flagged when no heading or label for it is found.
Effective date	Flagged when no heading or label for it is found.

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 is a GxP document?

Any document covered by a good practice rule: GMP, GLP, GCP or GDP. SOPs, batch records, logbooks, test records, deviation reports, CAPA records and validation protocols all count. Regulators expect each one to be clear, controlled and ALCOA+ compliant.

What is GxP document review?

It is the read a quality reviewer gives a document before approving it or accepting a record. The questions are simple: can someone follow it, is it complete, does it match the regulation, and does it meet good documentation practices. The checker handles the wording part of that read.

What are good documentation practices (GDocP)?

The rules for making and keeping GMP records so they are attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available. GDocP covers how you write an entry, correct a mistake, sign, date, review and archive.

Does the checker replace a QA review?

No. It hands your reviewer a marked-up copy so they start from the likely problems. It cannot tell whether a step is scientifically right or whether the floor follows it. Run it before QA review to cut a round of comments.

Can I check a Word document?

Yes. Open the .docx and the checker reads the body text on your computer. It skips headers, footers and text boxes. For a PDF, copy the text and paste it in; scanned PDFs need OCR first.

Which documents work best?

SOPs, work instructions, batch records, lab records, deviation and OOS investigations, CAPA plans, change controls, validation documents, audit reports and Form 483 responses. Anything written in English prose.

Is it free?

Yes, with no account and no limit. If you want a PDF of your review, we ask for an email so we can tell you when we publish new tools and FDA data.

Does Atlas see my document?

No. Your text never leaves the browser tab, and we turned off analytics and session recording on the tool. If you choose to save a PDF, the only thing we receive is the email address you type.

Other free tools for QA teams

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