Quality events
Batch record review by exception
Attach an executed batch record or paste an extract; the AI reviews it against the master record and limits and lists only the exceptions. You disposition each exception, link deviations and record a signed recommendation; batch disposition stays in your QMS.
In the portal: /app/batch-records
The review procedure
- Person
1. Create the review
Lot, record type, executed record and limits attached
- AI drafts
2. Review the record
Coverage and exceptions with quotes
- Person
3. Disposition each exception
Link deviation, accept, return or not an exception
- Person
4. Add missed exceptions
- Person
5. Record the recommendation
Release, hold, return or reject
- E-signature
6. Review and sign
- An exception linked to a deviation needs the deviation reference (e.g. DEV-2026-0214).
Start a review
- Step 1: Open Batch record review and choose New review.
- Step 2: Choose the Record type: electronic batch record export, scanned paper batch record, batch record extract (text) or other.
- Step 3: Enter the Lot or batch number (required), product and stage or line.
- Step 4: Attach the executed batch record (and the master batch record, specification or limits, deviation or change records, equipment or environmental logs), or paste an extract (up to 24,000 characters). One of the two is required.
- Step 5: Keep Run the AI review now ticked and choose Create and review.
Tip: Operator names in the record are read as signatures only.
Exceptions and dispositions
The AI reports coverage (each section reviewed, partly reviewed or not reviewed) and only the exceptions (E1, E2…): the step, what was recorded against what was required with the quote, the category, a severity (Critical, Major, Minor) and its suggestion. Entries that passed are counted, not listed.
| Category | Examples |
|---|---|
| Out of limit | A recorded value outside its limit |
| Missing entry / Missing signature or verification | A blank field, an unsigned step |
| Late or unexplained correction | A correction without date, reason or initials |
| Calculation error / Sequence or timing | Wrong yield, steps out of order |
| Equipment, material or label / Documentation practice / Other | Wrong equipment ID, unclear entry |
Disposition each exception (with a reason): Link deviation (give the reference), Accept with justification, Return for correction or Not an exception. Use Add an exception you found for anything the AI missed.
| Recommendation | Use when |
|---|---|
| Recommend release | No open exception affects quality |
| Hold pending deviation closure | A linked deviation is still open |
| Return for correction | Documentation must be corrected first |
| Recommend rejection | The batch should not be released |
Rule: The recommendation is signed here; batch disposition is decided and recorded in your QMS.
Before routing: the record must have been reviewed, every exception dispositioned, every linked deviation referenced and the recommendation recorded.