Industry
Pharmaceutical
Where the record matters as much as the result.
What presses on this sector
- Validation and documentation burden
- Data integrity expectations
- Batch record accuracy
- Change control on every system touching product
Where we typically help
Data capture for batch records
Automatic parameter capture with time stamps and user attribution, reducing manual transcription.
Packaging inspection
Label, leaflet and carton verification with retained evidence per pack.
Environmental and utility monitoring
Trending of utilities and environmental parameters with alerting on excursion.
Working within your constraints
Work is scoped around your validation approach and change-control process. We do not claim the system is validated: validation is an outcome of your qualification activity, which we support with specifications, test evidence and documentation.