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The situation
A batch record documents a manufacture end to end. Review before release is a regulatory requirement and a bottleneck: a qualified person reads a long record looking for the entries that are not routine.
Most of the record is routine. The review time is spent establishing that, which is necessary and almost entirely unproductive.
Why it is hard
Exceptions are contextual
An entry is an exception relative to the process definition and the batch's own history, not relative to a fixed threshold.
The record is part structured, part not
Some values come from equipment. Others are handwritten entries, comments and attached deviation references.
Review by exception has to be defensible
Reducing what a reviewer reads is only acceptable if the basis for excluding the rest can be shown.
How we approach it
Agentix reads the record against the process definition and surfaces the entries that are out of pattern, with the entry and the definition it was assessed against both cited.
The reviewer still sees the whole record. What changes is that they start at the entries that need judgement, and the basis for that ordering is visible.
What changes
- Exceptions surfaced against the process definition, with both cited
- Handwritten entries and attached references read alongside equipment data
- The full record remains available; only the starting point changes
- QA sign off required and recorded against the batch
Next
Is this your problem too?
Bring the version of it you actually have. We will tell you what it would take, including when the answer is that it is not worth doing.