A regulated laboratory system for records and control
A sterilization and testing laboratory moved from paper forms to a digital system that derives the customer report from the test results themselves — with full version traceability.
- Operational systems
- Regulated processes
- Priority ERP
- Traceability
- Sector
- Sterilization and laboratory services
- Status
- Running in production. The laboratory is accredited to ISO/IEC 17025.
The challenge
The laboratory process is recorded on an internal work document, and the report sent to the customer is derived from it. When that document is a paper form, the report is rewritten every time: every transcription is an opportunity for error, and every change to a form requires manual updating across all the test sets.
Why a standard implementation was not enough
An ERP knows what was ordered; it does not know what was measured. A fill-in PDF, on the other hand, cannot handle tables that grow with the number of samples, does not calculate in real time, and does not manage versions — it only freezes an appearance. In a regulated laboratory the document is not a record of the work: it is the product.
Architectural approach
Every document carries a template number and a version number. Every document issued in the past stays bound to the version that produced it, and an earlier version is never overwritten — because regulatory requirements demand retained history. A new document is always produced under the active version. The commercial context comes from Priority; the laboratory measurements stay in the laboratory system. That is an explicit boundary decision between the two.
What was delivered
- Fully digital work documents and customer reports
- Version management and traceable numbering for every document
- Real-time calculation from the recorded parameters
- Dynamic sample tables, including a negative control
- A document lifecycle: draft, final, and reopening by permission
- Role-based signatures and permissions