Most batch-record errors are not dramatic: a missed signature, a reading outside its range, a step started before the previous check was done, an operator not yet trained on a revised SOP. On paper, they are found days later in review. In Swat iQua Suite, the eBMR stops them as they happen.
- Hold points: a step cannot start while an earlier hold point or verification step is still open.
- Verification as a separate duty: the verifier must be a different person from the performer, with an e-signature.
- CPP and CQA limits: readings are checked against minimum and maximum; an out-of-limit reading raises a deviation from the step.
- Corrections: a correction supersedes the original value and never overwrites it.
- Training interlock: an operator cannot start a step without training on the SOPs linked to it.
- Evidence: step attachments can be required, and a missing required attachment blocks close.
Batches can be put on hold, resumed or cancelled, and steps skipped, blocked or unblocked — each with a recorded reason. The production order stays in sync, from released to in production to completed.
Yield tracking on every batch
Yield percentage is captured at close and classified against the yield window on the approved formula, and dispensing reconciles each weighing against its minimum and maximum. Yield becomes a fact on every batch record rather than a calculation at month end.
Lines that still need paper can run hybrid batch records: each paper copy is numbered, printed once and must be reconciled before the batch can close.
