USE CASE / VENDOR RELEASE VALIDATION
A vendor release changes
your validated LIMS.
A validation team is asked to assess the impact of a vendor's major release and validate it in house: what changed, how deeply each change was tested and why, and who approved the result.
Runs on TMS projects, Generate and execution
THE SITUATION
The QC lab's LIMS vendor has scheduled a release that adds an electronic signature to result approval, rewrites the audit-trail viewer and refreshes the dashboards. The validation lead has to assess each change, test the ones that touch GMP records most deeply, and close with a summary the quality unit can approve.
Vendor release 2026.3 to a cloud-hosted LIMS: a new electronic signature on result approval, a rewritten audit-trail viewer, and refreshed dashboards. The first two touch GMP records and get scripted testing; the dashboards get unscripted testing, as FDA's Computer Software Assurance guidance describes for lower-risk functions.
HOW IT RUNS
Who does what.
Each step is marked by who acts: your SMEs, the AI, or the record that remains.
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YOUR SMEs
Open a release project
Create a project for the release under the LIMS system and choose Vendor or platform release. TMS proposes its document plan: impact assessment, testing risk assessment, a revised URS, regression and UAT protocols, and a test summary. A line can be marked not needed, with its rationale.
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AI ASSISTS
Draft the impact assessment
Attach the vendor's release notes. Generate drafts the impact assessment from them and the current requirements, in the impact assessment's standard layout, for the validation lead to complete.
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YOUR SMEs
Decide what changes and how deeply to test
The validation lead confirms the impact of each release item and sets test depth by risk: scripted testing for the electronic signature and the audit trail, unscripted for the dashboards.
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AI ASSISTS
Revise the requirements and draft the protocols
The URS is revised as a new version within the project. Regression and UAT protocols are drafted from the requirements, each test case linked to the requirement it verifies.
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YOUR SMEs
Review and approve
Reviewers comment on a requirement, a heading or a passage. A document cannot go for approval while a comment is open, and approvers sign electronically.
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YOUR SMEs
Execute, and record what happened
Testers record each step's result with evidence. A failure is logged as a deviation against the step it came from. The dashboard check runs as an unscripted session in the same system.
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THE RECORD
Assemble the summary from the records
The test summary is assembled from the project's records, not written by a model: deliverables, results per protocol, deviations, traceability and open items. The audit trail records every edit, AI request, comment, signature and step.
WHAT YOU HAVE AT THE END
Evidence you can show.
- An approved impact assessment and testing risk assessment for the release
- A revised URS, kept as a new version beside the one it replaces
- Approved protocols with their reviewers, approvers and electronic signatures
- An execution record with step results, evidence and deviations
- Traceability from each requirement to the test cases and results that verify it
- A test summary report assembled from the records, reviewed and approved like any document
Qualisera supports your quality system. It does not replace your quality unit's review, approval or validation responsibilities.
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