A working application is only part of a regulated release. GTMI helps engineering and quality agree what needs to be demonstrated, then connects requirements, tests, and deployment evidence as the system changes.
For engineering and quality teams managing electronic records, signatures, validation, and inspection readiness.
Requirement + agreed risk
Test + result + software version
Review + approval + deployment
Quality retains validation approval and release authority.
Engineering and quality can be working from different views of the same system. A signature changes without its requirement being updated. An interface falls outside the test scope. The final record needs evidence that the application does not capture. Those gaps become expensive to resolve when a site is waiting to deploy.
Agree the intended use and system boundary.
Establish what each control must demonstrate.
Link results to the requirement and version.
Record review, approval, and deployment.
We help define the controlled functions, electronic records, signatures, and interfaces within the validation boundary. The client's risk model then guides requirements, traceability, and the IQ/OQ/PQ approach. We bring those decisions to quality while the design is still open to change.
Repeatable tests can support evidence for suitable functions. A scoped automation approach can use repeatable browser tests in controlled environments, with results linked to the requirement and software version. We apply that experience within the agreed validation strategy, with review and approval retained by the client.
A later release needs to show the change, its affected requirements and risks, the tests performed, and the version deployed. We connect source control, test execution, deployment records, and change governance so the evidence can be reviewed without reconstructing it across separate tools.
The service pages explain the work you can commission, the outputs and how it fits alongside your team.
The service explains the contribution and the decisions its outputs support. Where an example is shown, it uses fictional manufacturing data.
No. Automation can produce repeatable evidence for suitable functions within the agreed risk and validation model. The client retains quality judgement and validation approval.
Yes. The review can examine the current change process, traceability, test coverage, and deployment evidence to identify gaps affecting later releases.
Describe the planned release and the evidence you are struggling to assemble or review. A readiness review can identify the gaps and open quality decisions, then define a practical route to close them. Your quality organisation retains regulatory interpretation, validation approval, certification, and release authority.