Overview
One batch from line clearance to release, with the paper practice it replaced set beside it.
It removes the photocopied master batch record that went to the line with every production order.
Case study
Electronic batch record for a pharmaceutical manufacturer
Replacing the paper batch record: the photocopy issued to the line for every batch, the hand-written entries, and the page-by-page check after production.
How it was handled before
On a solid-dose tablet line, the approved master batch record was photocopied for every batch and issued to operators on paper.
Entries were hand-written and checked page by page once production had finished: a value outside its range could surface days later, with the batch already made. The release pack was assembled by hand from paper held in three separate departments.
What the system does
The record now runs alongside production.
Only the approved revision of the master record can be issued to the line, never a draft. Every value is checked against its acceptance range the moment it is typed. Operator, badge identity and time are not written by hand: the system records them. Each signature states its meaning — performed by, verified by, reviewed by, approved by — and the record locks once signed.
If a value falls outside its range, the step is held, the rest of the module locks, the record cannot be closed, and the shift lead is notified. The out-of-specification value is never overwritten: the re-test sits beside the original in the audit trail, with the reason for change and a second-person verification.
At review, quality assurance works through five exceptions instead of sixty-three steps.
The screens
Master batch record configurator
The template behind the record: field label, unit, accepted values, who must verify, and which of the three defined behaviours applies when a value falls outside its range.
A draft cannot go to production until it is approved.
Execution by line operators
A drying step as the operator sees it: the instruction taken from the approved revision, each value beside its own range, and the second person who must confirm.
Time and identity are written by the system, not by the operator.
Here, a result outside specification the moment it is typed.
The step is held, the following steps lock, the record cannot be closed, and the shift lead is notified.
Quality review of the master batch record
Five revisions of the same master record, with the batches run against each one and approval still open on the latest.
A superseded revision stays readable, but can never be issued to a line again.
Quality review of a completed batch record
Review by exception: 58 of 63 steps need no review; the five that do sit together with the deviation and its disposition.
Audit trail
Every value change, rule decision and signature in a single append-only list, each entry chained to the one before it.
Nothing is edited or deleted, so anyone can reconstruct who changed a value and why.
Batch release
Release in one place: yield reconciled against theoretical, in-process results checked against specification, and every signature behind the batch.
One file replaces the pack held in three departments.
Result
- 50%
Batch record completion time
- 70%
Time spent counting production hours per operator
Paper eliminated. The timings of each step remain as historical data, available for later analysis.
Confidentiality
The images are a representative reconstruction: the original system is covered by a non-disclosure agreement, and every name, batch number and result shown here is invented for demonstration.
Contact
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