Question 2 of 6 Fundamentals Concept
What should be tested when a LIMS workflow is changed?
Short answer
Test a LIMS change against user needs and data integrity risks, including identities, permissions, business rules, instrument interfaces, audit trails, historical records and recovery.
Why
For an updated specimen status workflow, begin with the approved requirement and an impact assessment. Build traceability from each changed rule to positive, negative and boundary test cases. Check permitted transitions, duplicate sample handling, barcode exceptions, chain of custody, user roles and result approvals.
Verify that rejected imports remain visible, with a reason and a path for authorised resolution. Test how historical samples are displayed and whether exports or dashboards change meaning. Where data migration is needed, reconcile counts, values and identifiers, and validate that audit history remains available.
Capture evidence of testing, deviations, approvals, production release and rollback. Configuration of a vendor product can still alter a validated business process. The depth of qualification depends on intended use and relevant quality regulations, not simply on the size of the code diff.
Common mistakes
- Assuming that a low-code configuration change cannot affect a validated workflow
The interviewer might ask next
Which records would you review after production release to confirm the change works as intended?