SOP Checker

Every SOP has a few words an auditor will question. "Clean as appropriate." "Check periodically." "The operator should." Paste your procedure or open the .docx, and the SOP Checker marks each one, suggests the fix, and lists the sections you left out.

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82 words7 vague language2 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.
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 SOP Checker

Step 1
Paste the SOP or open it as a .docx. Try the example first: it has seven problems.
Step 2
Read each highlight and the suggested fix, then check the list of missing sections.
Step 3
Swap every vague word for a number, a trigger or a role, and save the review for your QA reviewer.

What the SOP Checker looks for

Words that turn a step into a judgment call

"As appropriate", "adequate", "if necessary", "etc." and 36 more. Each comes with the replacement an auditor expects.

Sections you forgot

Purpose, scope, responsibilities, definitions, records, references, training, revision history, approvals and the effective date.

The CFR references you cite

Every 21 CFR citation pulled into one list, so you can check your references section against the steps.

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 makes a good SOP?

Hand it to a trained operator on their first day in the suite. If they can do the task the same way you would, and an auditor can later check that they did, it is a good SOP.

That takes three things in every step: a trigger (when), a limit (how much, how long, how often) and an owner (who). Format matters less than people think, and a neat template full of "as needed" still gets cited.

Which words should you avoid when writing an SOP?

These are the words the SOP Checker marks. Most of them are fine in a training slide. In a controlled procedure they hand the decision to whoever is on shift. "Should" and "may" read as optional, so required steps use "must" or "shall".

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.

What sections does an SOP template need?

Most GMP SOP templates carry these sections, in roughly this order. The checker reports which ones it cannot find in your text.

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.

How does FDA write up a weak SOP?

Investigators cite procedures that are missing, unclear or not followed. For drugs that is usually 21 CFR 211.100(a) for production and process control or 211.22(d) for the quality unit. In the Atlas Form 483 dataset (774 drug inspections citing Part 211, January 2025 to September 2026), 211.22 shows up at 352 inspections and 211.100 at 224.

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

How do you review an SOP?

Read it as someone who has never done the task. For each step ask: when does it happen, what is the limit, and who does it? Replace vague words with numbers, name the record each step creates, and confirm purpose, scope, responsibilities, references, approvals and revision history are there.

What should an SOP template include?

A title and number, purpose, scope, responsibilities, definitions, numbered steps, the records produced, references, training needs, revision history, approval signatures and an effective date. The SOP Checker tells you which of these it cannot find.

What is an SOP review checklist?

The list a reviewer works through before approving a procedure: steps are clear and testable, roles are named, frequencies and limits are numbers, records are defined, references are current, and the format follows document control. The checker covers the wording and section items.

How do you write an SOP that passes an audit?

Write each step as an instruction with a trigger, a limit and an owner. Replace "periodically" with a frequency. Name the record each step produces. Then walk the floor and make sure people do what the SOP says, because auditors cite the gap.

What is the standard SOP format?

Title and number, purpose, scope, responsibilities, definitions, procedure, records, references, training, revision history, then approvals with an effective date. Layouts differ between companies; auditors look for the elements, wherever they sit.

Is "should" acceptable in an SOP?

Not in a required step. An operator who skips a "should" step has arguably followed the SOP. Use "must" or "shall" for requirements, and keep "should" for guidance text outside the numbered steps.

How often should SOPs be reviewed?

Most companies set a periodic review every two or three years in their document control SOP, plus a review whenever the process, equipment or regulation changes. FDA sets no single interval for drugs; it expects procedures to stay current and be followed.

Can the SOP Checker read Word files?

Yes. Open the .docx and the checker reads it on your computer. Nothing is uploaded. For a PDF, copy and paste the text.

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