Approved masters, frozen into every batch
A batch in Swat iQua Suite can only be created from a released production order. At that moment it snapshots the exact approved versions of the product, formula, process and specification, so the batch is reproducible and never depends on a master that changes later. The process master defines each step’s operation type, criticality and instructions, and whether it needs verification, a signature, an attachment or a hold point.
Execution with the checks built in
- Hold points: a step cannot start while an earlier hold point or verification step is still open
- Verification is a separate duty — the verifier cannot be the performer — and is e-signed
- Critical process parameters are checked against their minimum and maximum; an out-of-limit reading raises a deviation from the step
- Corrections supersede the original value and never overwrite it — both stay on the record
- Training interlock: an operator cannot start a step unless trained on the SOPs linked to it
- Step evidence attachments, with required attachments blocking close
- Batch hold, resume and cancel, and step skip, block and unblock — each with a recorded reason
A controlled close
Close is e-signed and is refused until every required step is done, no step is blocked, hold points are cleared, out-of-limit readings are resolved and any hybrid paper copy is reconciled. Yield is captured and classified against the formula’s yield window. The Executed Batch Record PDF then shows every step, parameter and correction, the signers, deviations, attachments and the full audit trail — and every print is logged.
21 CFR 211.188 expects the batch record to show what was done, by whom, against which master, with the parameters, yields and investigations behind it. Swat iQua Suite is designed to support that content; the regulated company remains responsible for its batch records.
