Electronic batch record piloted on the packing line
Ergopharm has piloted an electronic batch record on its packaging line, replacing the paper record for that operation with a validated system that enforces the sequence of checks rather than relying on them being remembered.
The advantage of an enforced sequence is that a step cannot be signed before the step it depends on. Line clearance must be completed and verified before the line can be released for the next batch; reconciliation figures must balance before the record can be closed. Errors that paper allows to pass to review are caught at the moment they are made.
“The system's real value is the signature it will not let you give yet.”
Validation followed the site's computerised-system lifecycle, with the audit trail configured, user roles segregated and the system's behaviour under failure tested — including what happens to a partially completed record if the system is interrupted mid-batch.
Paper remains the fallback, with a defined procedure for reverting so that a system failure never becomes a manufacturing failure.
Key facts
- Scope
- Packaging operations
- Enforces
- Step sequence, line clearance, reconciliation balance
- Validated
- Full lifecycle, including interrupted-batch behaviour
- Fallback
- Defined reversion to paper