All our workCase study
Qualima
ISO 15189 quality management software for laboratories: electronic signature, tamper-proof audit trail, offline operation.
The context
- An ISO 15189-accredited laboratory must trace every document, every piece of equipment and every non-conformity
- Paper binders and spreadsheets: multiple versions, evidence hard to find during audits
- Regulatory requirement: who did what, when, and with what approval
What we did
- Document management with versioning and approval workflows
- Electronic signature by PIN code at every approval
- Tamper-proof audit trail: every action is timestamped and can no longer be changed
- Tracking of equipment and metrology, non-conformities and corrective actions
- Offline operation, with sync when the network comes back
The results
- 32 cloud functions, about 23,000 lines of code
- Security rules tested automatically, plus 15 browser tests
- In pilot at a medical testing laboratory
- Built for audits: every piece of evidence found in a few clicks
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