Worked scenario
Signed at the end of the shift for steps taken across it
A batch record completed retrospectively is complete and not contemporaneous, and the distinction is the entire point of keeping one.
4 min read
Batch records exist to demonstrate that a defined process was followed. Their value depends on being made as the process happens.
Blocks of entries share one time
Completed at the end of a shift, a record shows a sequence of steps with implausibly similar timings. It is not falsified — it is remembered — and it does not demonstrate what it is meant to demonstrate.
The limit of what a system decides
It does not state your GMP obligations or what your records must contain. Those come from your own quality system and your regulator. Capture at the step makes the record contemporaneous; it does not define what is required.
What changes
- Entries captured at the step, with time and operator
- Deviations recorded when they occur, not reconstructed
- Records retrievable by batch for review
- Gaps visible before the batch is released
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