Batch release: every manufactured lot dispositioned on the evidence of its own records
The QLogix Batch release module is batch release software that puts QA's disposition of a manufactured lot on a dossier the system reads from the records themselves. The work order and its yield, the bill of materials it was made on, the executed batch record and its review, every component lot issued to it, every LIMS sample of the lot and of its in-process lots, and every deviation, investigation, CAPA, change control and complaint tied to the lot are checked each time the dossier is read. A lot is released only when nothing fails: the batch record is approved for release, every test is done, reviewed and within its specification, and every quality event of the lot is closed. QA records the disposition and where the lot goes, review and approval signs it, and the approval releases the lot in the ERP with that signature, ready to dispatch to a distribution center or a client site.
What the module does
- The release dossier, read from the records rather than typed: the lot in quarantine and within its expiry, the work order complete with its yield inside its limits or accepted by QA, the reconciliation, the bill of materials in force when the lot was made, and the sales orders it was planned for.
- The batch record checked for its release: the executed MES batch record signed Approved for release, or, for a paper record, a signed batch record review recommending release.
- Every component lot issued to the work order read as it stands today: a raw material or component rejected or put on hold after it was used fails the release of the product it went into, and a supplier suspended or disqualified since is flagged.
- QC testing to the specification: release testing on file against the item's specification, every test that holds release registered from the work order's schedule, every sample of the lot and of its in-process lots with every test done, reviewed and approved, every result within its limits, and samples tested against a specification since superseded flagged.
- Quality events to closure: every deviation, investigation, CAPA, change control and complaint linked to the lot, its work order, its batch record or its samples, or named on a deviation of the batch record, must be closed before the lot is released. Records that only name the lot number are found too and are closed, linked, or set aside with QA's reason.
- Checks that pass, fail or warn: a failing check blocks a Released disposition, a warning is answered in the rationale, and the dossier is checked again at every signature, so a deviation opened or a result out of specification during the approval stops it.
- The disposition, Released or Rejected, with its rationale and conditions, and the destinations of a released lot: distribution centers, and client sites against their sales order lines, with the quantity each receives.
- The approval carried out at once: the lot is released in the ERP with the approver's signature named on the lot's decision and moved to finished goods, or rejected to the reject cage, and the batch records that use it follow the decision.
- Dispatch to each destination: shipments against the sales orders, or dispatches to a distribution center or a client site that name the release, each leaving the inventory and traced to the release, and a release certificate exported as a locked PDF.
How it fits the platform
Batch release closes the product order flow that runs through the ERP: a sales order line is planned for manufacture as a work order on the bill of materials in force, the work order designates the lot number from the product's numbering scheme, issues the materials from released lots and opens its MES batch record, and its scheduled tests register their samples in the LIMS. The order flow on the work order, the lot and the sales order shows every step from the customer's order to the dispatch, and the ERP's traceability page follows a lot up to the received materials and their suppliers and down to every customer who received it.
Q Intelligence lists and reads batch releases with their stage and decision, and its lot trace follows a released lot to its shipments. The document hub indexes every release, and the audit trail export covers batch releases under their own area.
Where people decide
The system reads the dossier and says what passes, what fails and what to read. QA decides: it settles what fails in the records themselves (closes the deviation, has the results approved, accepts a yield), sets aside a record that concerns another lot with a reason, records Released or Rejected with the rationale, names the destinations, and the approvers sign the release decision.
Questions about Batch release
What does the release dossier check?
The lot (awaiting its disposition and within its expiry), the work order (complete, yield settled, made on the bill of materials in force), the batch record (approved for release), the component lots (still released), the QC samples of the lot and its in-process lots (every test done, approved and within specification) and the quality events tied to the lot (all closed). Each check passes, fails, warns or does not apply, and the dossier is read again at every signature.
Which quality events must be closed before release?
Every deviation, investigation, CAPA, change control and complaint linked to the lot, its work order, its batch record or any of its samples, or named on a deviation of the batch record. Records that only mention the lot number are found by a search and must be closed, linked or set aside by QA with the reason they concern another lot. Open change controls on the product's bill of materials, master batch record or item are shown as a warning.
What happens when QA approves the release?
The approval signs the disposition and locks the record, and the lot is released in the ERP at once with the approver's signature named on the lot's decision. It moves to finished goods and can be dispatched to the destinations the release names. A rejection moves the lot to the reject cage.
Where can a released lot be shipped?
To the destinations named in the release: distribution centers, and client sites against their sales order lines, each with its quantity. Shipments against a sales order are recorded on the order; dispatches to a distribution center or a client site without an order are recorded on the lot, naming the release. Either way the lot traceability shows where every unit went.
How is it licensed?
Per user per month, on its own or with the ERP, MES and LIMS, ordered by purchase order from the client portal. There is no card payment or self-serve plan.
Other modules
- Change managementGMP change management software for document, equipment and facility changes: AI impact and ICH Q9 risk assessment, GMP requirements per item, approval and closure.
- Document controlDocument control software for GMP: AI review of each SOP draft, signed approval on an effective date, read-and-understood training signatures and periodic review.
- TrainingGMP training management: a training matrix by job function, SOPs read and understood with a Part 11 signature, OJT signed by manager and QA, retraining on change.
- Risk assessmentQuality risk management software for FMEA under ICH Q9(R1): design, process, equipment and CSV templates, RPN thresholds, mitigation tracked to residual risk.
- Regulatory submissionsRegulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source.
- Gap assessmentGap assessments against FDA, EU GMP, ICH and PIC/S: every requirement cited from the regulatory library, rated, remediated with evidence and closed with signatures.