Deviation report generator
Fill a structured deviation report in a few minutes on your phone or PC. The questions adapt to the deviation type, a transparent scoring matrix suggests minor, major or critical (you decide), and the tool writes clear report text from your answers. Print it, save as PDF or download .docx, then continue to the investigation, CAPA and effectiveness check with the details carried forward.
Deviation report
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Identification
Why this matters
Record both when the event happened and when it was detected. The gap between them shows how long product may have been affected and helps decide which batches to include.
Good practice / example in-house approach — follow your SOP.What happened
Why this matters
Record the deviation and the reason for it. US cGMP requires that any deviation from written production and process control procedures is recorded and justified.
Source: 21 CFR 211.100 — Written procedures; deviations (US FDA, current eCFR text)Why this matters
For environmental monitoring excursions, record the cleanroom grade, sampling location, method, the level exceeded (alert or action) and the organism identification if available. Alert and action levels come from your site's monitoring programme.
Good practice / example in-house approach — follow your SOP.Why this matters
For equipment breakdowns, record the qualification status and whether a batch was in process. Assess whether repair work needs requalification under change control.
Good practice / example in-house approach — follow your SOP.Why this matters
For documentation errors, identify which data integrity attribute was affected (ALCOA+: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available) and whether the original data can be recovered.
Good practice / example in-house approach — follow your SOP.Containment and impact
Why this matters
Describe what was done immediately to contain the event (for example stopping the activity, quarantining material, segregating batches). Containment is not the same as CAPA.
Good practice / example in-house approach — follow your SOP.Classification
Why this matters
Target dates are set by your SOP. A common site practice is to close deviations within 30 days unless an extension is justified; this is an example in-house criterion, not a regulatory requirement.
Good practice / example in-house approach — follow your SOP.Report text and export
Frequently asked questions
Is my deviation data uploaded anywhere?
No. Everything you type is stored only in this browser (localStorage) and the documents are created on your device. Use “Save to file” to keep a copy and “Delete all my data” to remove it.
How does the tool suggest minor, major or critical?
It scores five answers — product quality impact, patient safety, GMP/regulatory impact, batches affected and repeat occurrence — on a transparent example in-house matrix and shows which answers raised the score. You always set the final classification as per your SOP.
Why do the questions change?
The questions follow the deviation type. An environmental monitoring excursion asks for grade, location, organism and alert/action level; an equipment breakdown asks about qualification status and batch impact; a documentation error asks which ALCOA+ attributes were affected.
Can I use the output as my official form?
Use it as a well-structured draft. Transfer it to your controlled form or QMS system if your SOP requires, and get QA review and approval. It does not replace your site's SOPs.
What should I not enter?
Do not enter patient names, confidential formulas or anything your company does not allow outside its systems. Use the Anonymise switch to mask product names and batch numbers in the output.
Related guides on pharmaguideline.net
- Deviation Management in Pharma: Complete Guide (GMP, CAPA)
- SOP on Handling of Incidents and Deviations (Example)
- Quality Risk Management in Pharma (ICH Q9 R1) Explained
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