Industry
Digitalisation for the pharmaceutical industry
GMP compliance, end-to-end traceability and audit-proof batch documentation — delivered without paper, without errors and without production downtime.
Requirements in the pharmaceutical industry
- GMP-compliant documentation of every batch — from raw material to release
- Audits take days because paper archives have to be searched
- Batch traceability in a recall has to be possible in hours, not days
- 21 CFR Part 11 / Annex 11 requirements for electronic records
- Validation and qualification of every digital change (CSV)
What we deliver for pharma customers
RFID traceability
Complete batch tracking from raw material receipt to release — with RFID gates at all key points, linked to the LIMS.
Electronic batch records
Digital test records with timestamp, operator identification and immutable archiving — compliant with GMP and Annex 11.
Audit-ready archive
With a digital archive, audits that used to take days are completed in hours. A complete audit trail, filterable instantly.
CSV-compliant implementation
Validated rollout according to GAMP 5: IQ/OQ/PQ documentation, risk analysis and change control included.
Reference projects
Pharma · Vienna
RFID traceability in pharma
−80% audit duration, 0 documentation errors