Laboratory information management system goes live
A validated laboratory information management system has gone live at the Vadodara site, moving sample registration, test allocation, result entry and approval out of paper worksheets.
The gain is not speed but traceability. Every sample now carries an identity from login to disposal, every result is attributable to an analyst and an instrument, and specification limits are applied by the system rather than by transcription. Out-of-specification results are flagged at entry and cannot be quietly overwritten.
“The system did not make us faster. It made every number answerable.”
The system was validated against a user requirement specification, with installation, operational and performance qualification, and with the audit trail configured and reviewed before release into use. User roles were configured so that no individual can both perform and approve the same test.
Paper remains where it is genuinely better, and hybrid records are defined explicitly rather than allowed to emerge by accident.
Key facts
- Scope
- Sample login, workflow, result entry, approval
- Validated
- URS · IQ/OQ/PQ, audit trail configured
- Segregation
- Perform and approve cannot be the same user
- Hybrid records
- Defined explicitly where paper is retained