Batch record review software: executed batch records reviewed by exception
The QLogix batch record review module is batch record review software that reviews an executed batch record by exception and lists only the entries that do not meet their instruction, limit or good documentation practice. The AI checks every entry it can read in an electronic batch record export, a scanned paper batch record or a text extract against the master batch record and limits attached, recomputes calculations and reconciliations, and reports its coverage section by section, so the reviewer knows what was and was not checked. The reviewer dispositions every exception, links the deviations, adds anything the AI missed and signs a recommendation for release, hold, return or rejection; the batch disposition itself is decided and recorded in the site's QMS.
What the module does
- A review per lot in the BRR series: the record type (electronic batch record export, scanned paper batch record, batch record extract or other), the lot or batch number, the product and the stage or line.
- The executed batch record attached with the master batch record, specifications or limits, deviation or change records and equipment or environmental logs, or an extract of up to 24,000 characters pasted.
- Each readable entry checked for values against limits; required entries, signatures, dates and second-person verifications; corrections initialled, dated and explained; calculations and reconciliations recomputed; sequence and holding times; component lots, equipment IDs and labels; and a deviation reference for every out-of-limit value or missed step.
- Coverage reported section by section as reviewed, partly reviewed or not reviewed, with what could not be read; illegible entries are reported, never guessed, and a missing limit is listed rather than invented.
- Only the exceptions listed (E1, E2…), each with the step, what was recorded against what was required, the exact quote and its location, a category, a severity of Critical, Major or Minor with the rationale and a suggested action; entries that passed are counted.
- Exception categories: out of limit, missing entry, missing signature or verification, late or unexplained correction, calculation error, sequence or timing, equipment, material or label, documentation practice and other.
- Each exception dispositioned with a reason: link deviation with its reference, accept with justification, return for correction or not an exception; exceptions the reviewer finds are added to the same list.
- A recommendation of release, hold pending deviation closure, return for correction or rejection, routed for review and approval with electronic signatures.
How it fits the platform
An exception linked to a deviation carries the deviation's reference, and the deviation is investigated in the Investigations and CAPAs module, where it can lead to a CAPA that names batch record review as its origin. Connected records link the review to the deviations, investigations and CAPAs, and suggest other records that share the lot or the equipment.
For batches executed in the QLogix MES, each step is executed and verified with signatures as it happens, entries outside their limits are flagged on the batch, and QA reviews and releases the batch there. Built-in alerts flag batch review exceptions left open after 3 days and a batch on hold or returned after 7 days, and the work queue shows each review's stage and what it is waiting for.
Where people decide
The AI checks the entries and lists the exceptions with their quotes and a suggested action; it never dispositions an exception, records the recommendation or releases a batch. The reviewer dispositions every exception with a reason, adds what the AI missed and records the recommendation; the reviewers and approvers sign it. The batch disposition is decided and recorded in the site's QMS by the people authorized to release.
Questions about Batch record review
What is review by exception for batch records?
Review by exception means the reviewer reads what does not meet its requirement instead of every entry that does. The AI checks each readable entry against its instruction, limit or good documentation practice and lists only the exceptions, with the quote and its location. Entries that passed are counted, and coverage is reported section by section so the reviewer sees what was not checked.
What does the AI check in an executed batch record?
Values against their limits, missing entries, signatures and second-person verifications, corrections without a date, reason or initials, calculations and reconciliations such as yield and labels, sequence and holding times, the identity of component lots, equipment and labels, and a deviation reference for every out-of-limit value or missed step. It works only from the documents provided: when a limit is not available, it says so and lists the missing limit for the reviewer.
Can it review scanned paper batch records?
Yes. A scanned paper batch record, an electronic batch record export or a text extract can be reviewed. Pages or entries that cannot be read are reported as partly reviewed or not reviewed with a note; the AI does not guess at illegible entries.
Does it release the batch?
No. The reviewer records a signed recommendation: release, hold pending deviation closure, return for correction or rejection. Batch disposition is decided and recorded in the site's QMS, and the AI never releases a batch.
Is the review signed under 21 CFR Part 11?
The recommendation is routed for review and approval with electronic signatures that ask for the signer's email and password again. Every AI review, disposition, added exception and signature is an entry in a hash-chained audit trail, and the approved record is locked.
How is it licensed?
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.
Reading
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