# Compliance and validation

[Website page](https://www.gt-intelligence.com/services/compliance-validation)

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.

## 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.

## 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.

## Quality acceptance belongs to the client

GTMI prepares the agreed documentation, tests and evidence, and records issues for review. The client retains regulatory interpretation, risk classification, validation strategy approval, system certification, evidence acceptance and final release authority. Quality and system owners decide how deviations are handled. Those review points are agreed alongside development and deployment.

## 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.

## Evidence deliverables

- Validation scope and planning documents
- Requirements-to-test traceability
- Test protocols and execution evidence
- Release evidence prepared for client review

## 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.

A requirement should lead to a planned check and a reviewable result for the release.

## Starting material

The intended use, approved validation approach, current requirements, and release milestone.

## Platforms

GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, Automated testing