Planning and traceability
URS boundaries, validation planning, risk links, and the relationship between requirements and evidence.
Service
Compliance and validation
Plan the evidence your system needs for release.
GTMI supports validation planning, requirements traceability, test design, and automated evidence for regulated manufacturing software, within your quality system.
For quality, validation, and engineering teams planning evidence work alongside system development or change.
- 01
Requirements
URS and system boundary
- 02
Risk and planning
Validation plan and traceability
- 03
Test evidence
Protocols and execution records
- 04
Client review
Quality acceptance and release
A requirement should lead to a planned check and a reviewable result for the release.
What GTMI takes on
Validation support within your quality system
GTMI supports the validation work for a manufacturing application or system change. You can commission requirements and traceability work, test design, IQ/OQ/PQ documentation or preparation of a release evidence package. The work follows the client’s quality system and approved approach. The traceability entry and evidence index show which requirements have planned checks, which results are missing and which issues need review before the client can assess release readiness.
Records and signatures
Requirement and test support for electronic records, audit history, and electronic signature functions.
Test design and execution
IQ/OQ/PQ structures, test scenarios, execution records, and defined automation coverage.
Release evidence
Evidence assembled against the approved scope, with test results, open issues, and review responsibilities recorded.
The delivery work
Plan the evidence against the intended use
The work begins with the system boundary, intended use, relevant records and signatures, and the risks assigned by the client. GTMI connects requirements to functions and planned tests, records interface assumptions, and defines the evidence expected at each delivery stage. The planning accounts for the applicable GAMP 5 and 21 CFR Part 11 requirements identified by your quality team.
Develop tests and an automation approach
Test design can include repeatable application checks and an automated-evidence pilot where the approved strategy permits it. An automation scope can use Playwright checks, controlled test environments and results linked to your test-management system. The plan specifies the functions covered, environment controls, result records and review process. We organise manual and automated evidence under the client’s agreed traceability and release requirements.
Evidence deliverables
- Validation scope and planning documents
- Requirements-to-test traceability
- Test protocols and execution evidence
- Release evidence prepared for client review
Platforms
- GAMP 5
- CSA
- 21 CFR Part 11
- EU Annex 11
- Automated testing
Illustrative example: fictional manufacturing data
Follow one requirement to a release decision
The fictional operator workflow must show the released instruction revision and retain it with the production record. This entry shows a proposed check and the evidence fields needed for review.
| Index field | Sample entry |
|---|---|
| Requirement R-01 | Show the released revision at task start, retain it with execution and prevent selection of an obsolete instruction |
| Risk to assess | Using an obsolete instruction could lead to incorrect work; client risk classification is not assigned |
| Proposed test T-01 | Offer revisions 03 and 02; check selection of released 03, rejection of obsolete 02 and revision attribution in the record |
| Expected result | Revision 03 shown and retained; obsolete revision 02 cannot be selected |
| Execution record E-01 | Template only: application version, environment, data, tester, date, expected/actual results and deviations |
| Actual result | Not recorded; test not executed |
| Evidence status | Planned; no result or signature supplied |
| Client review | Not submitted; no acceptance or release decision recorded |
An evidence index shows which checks are planned, where execution results are missing and which deviations need review. GTMI can prepare the requirement links, tests and evidence package. The client assesses risk, accepts evidence and authorises release within its quality system.
Working together
Evidence packages and release support
Scope a specific documentation or test package, or bring GTMI into the evidence work for a pilot or release.
Traceability and test documentation
Planning, traceability, or test documentation for a specific system boundary, reviewed by your quality team.
Automation or release support
An evidence pilot with a defined scope, or a delivery role that follows agreed tests and evidence through the client’s review process.
Where next
Define the engagement
Scope the evidence work you need
Describe the system change, the next release and where evidence is missing or difficult to review. We can identify a traceability package, test-design assignment, automation pilot or release-support scope with your quality and engineering owners. Leave confidential details out of the initial enquiry.