Record the deviation when it happens, not when someone remembers it.
When a value is out of limit or a time is exceeded, the deviation is raised from the batch step itself, with the context already attached. QA classifies it, investigates, assesses impact and links the CAPA, all against the same batch.
Captured in the record
- Batch, step, room and equipment context
- Recorded value against the limit
- Immediate action taken
- Classification and rationale
- Root cause and impact assessment
- CAPA reference and closure signature
DEV-2026-0381 · Batch 2611
Minor · Closed- EventGranulation drying time exceeded by 6 min
- Raised fromStep 27 · FBD-02 · auto-detected
- Immediate actionLOD checked · 1.8% (limit NMT 2.5%)
- Impact assessmentNo impact on quality · QA
- Root causeInlet air temperature drift
- CAPACAPA-0122 · sensor recalibration
How it flows
- 1
Detect
The step flags the event and opens a deviation.
- 2
Classify
QA sets the category and owner.
- 3
Investigate
Root cause and impact are recorded.
- 4
Close
CAPA linked, justification signed.
What your team works with every day.
Raised from the step
Out-of-limit values and exceeded times raise a deviation automatically. Operators can also raise one manually from any step.
Classification
QA classifies each deviation as critical, major or minor using your own criteria, with the reason recorded.
Investigation
Capture the investigation, root cause method and evidence in one place, with tasks assigned to named people.
Impact assessment
Assess impact on the batch, other batches and the product. The batch cannot be released while the assessment is open.
CAPA link
Link corrective and preventive actions to the deviation, or push them to your existing QMS through the integration.
Trend view
See deviations by product, room, equipment and cause to spot repeats before they become an audit finding.
About Deviation Desk
We already have a QMS for deviations. Do we need two systems?
No. Deviation Desk can capture the event on the floor and hand it to your QMS, or manage the full lifecycle if you do not have one.
Can a batch be released with an open deviation?
Not by default. QA Release blocks release until deviations linked to the batch are closed or formally justified by QA.
Your next batch could leave the cleanroom like 2611.
Tell us about your products and lines. We will walk your QA and production heads through one of your own batch records, step by step.
- Record
- Your plant · first production line
- Meaning
- Approved for a live walkthrough
- Signed by
- You, in under two minutes