Compliance and quality

Experience in regulated delivery

GTMI supports validated manufacturing software delivery within the client's approved quality system. The scope can cover requirements, validation planning, electronic records and signatures, test evidence, release controls, system interfaces and site deployment. We prepare the engineering work and evidence for assessment within that quality system.

Electronic records and signatures

GTMI can help teams translate electronic record and signature requirements into system behaviour and testable controls. Depending on the client system and validation strategy, the work may address:

• Audit trail, attribution, and record-retention requirements.
• Electronic signature meaning, identity, and approval behaviour.
• Role and access requirements across operator, supervisor, and quality workflows.
• Data-integrity expectations for capture, review, correction, and controlled output.

The client quality organisation defines the applicable requirements and approves the resulting controls and evidence.

Validation planning and evidence

GTMI supports risk-based validation delivery in 21 CFR Part 11 and GAMP 5 contexts. Relevant work can include:

• User requirements and validation-boundary definition.
• Validation planning and IQ/OQ/PQ test structures.
• Traceability between requirements, risks, tests, and release evidence.
• Automated test execution where the client's risk model supports it.

The automation approach can use repeatable browser tests in controlled environments and link the results to your test-management system. Automated results can form part of the validation evidence. They do not replace quality review or release approval.

Release and change control

Source review, automated checks, test records, artifact handling, deployment evidence, and environment ownership can all contribute to a controlled release path. GTMI links those engineering records to the client's change and validation process and documents who reviews them, deploys the release and provides support afterwards.

Client quality ownership

GTMI provides software, architecture, delivery, and validation support. The client remains responsible for its quality system, regulatory interpretation, validation approvals, certification decisions, audit responses, and release authority. Engagements define that boundary explicitly so technical delivery and quality governance remain connected without transferring responsibilities that belong to the client.