Runnable simulator field guide
Pharmaceutical batch-record PLC scenario: test checklist
Direct answer
The learner can link recipe and material identity to ordered phase results, record exceptions and distinguish controller events from a complete compliant record.
Written for automation learners exploring how a regulated batch sequence can retain reviewable process and operator evidence.

Scenario setup
Batch, recipe and material identity, equipment status, phase parameters, operator action, timestamps, source, result, exception, review state and change history.
I/O and state map
Approved request through equipment allocation, phase execution, measured values, alarms, interventions, completion evidence and reviewable record.
Normal run
One declared batch preserves ordered identity, parameters, results, timestamps and exceptions across normal phase transitions and completion.
Boundary run
Wrong material, missing equipment, parameter out of range, sensor fault, manual intervention, aborted phase, duplicate action, time change and controller restart.
Injected fault
An identity, recipe, equipment, parameter, measurement, phase-state, operator, timestamp, exception or record-integrity mismatch.
Target check
The production solution specified, validated and governed through current quality, data-integrity, cybersecurity and regulatory procedures.
What should a PLC batch record contain?
Retain traceable batch and recipe identity, equipment and material context, phase parameters, measured results, alarms, interventions, exceptions and trustworthy timestamps.
Does a PLC event log make a system Part 11 compliant?
No. Compliance depends on the complete validated system and procedural controls, including access, audit trails, record integrity, review and electronic signatures where applicable.