In Swat iQua Suite, the master batch record is not a Word file that gets copied for every batch. It is a set of approved records that the rest of manufacturing reads from. The product definition says what is being made and how the site makes it. The master formula says how much of each material goes into a batch of a given size and what yield is acceptable. The process master says which steps run, in what order, and which of them need a second-person verification, a signature, an attachment or a hold before the next step can start.
Masters drive planning, dispensing and execution
When a planner raises an order in Production Planning, the order snapshots the approved product, formula, process and specification versions, and release is refused if any of them is no longer approved and current. Dispensing scales the formula’s BoM to the planned batch size. The eBMR expands the process master into the batch’s steps, applies the hold-point and verification flags, and classifies actual yield against the formula’s yield window when the batch closes.
- Production Planning checks that every master version is approved and current before release.
- Dispensing fans the BoM out line by line, with the min/max window used for reconciliation.
- The electronic batch record enforces the step flags set in the process master.
- API recovery reads the per-line reuse rules before admitting a recovered lot.
Why three separate masters
Keeping the formula and the process apart means a change to a manufacturing instruction does not force a re-approval of the BoM, and the reverse. Each change is still governed: revising creates a new draft, the same three-way approval applies, and the audit trail shows the old and new values with a reason. Masters are also available through the REST API for teams that maintain product data in another system.
Masters shared to other sites are read-only there. A site that needs a local variation forks the master into its own copy, so group-wide masters cannot be changed by one plant.