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Services · Quality Assurance

Quality you can put in front of an auditor.

Test management, test engineering, and regulatory alignment with GxP, GAMP 5, GCP, and IEC 62304 for regulated and modern engineering teams.

What we do

We bring test management, hands-on test engineering, and regulatory alignment to teams that have to prove quality, not just claim it. We treat test code as production code and build traceability from requirements through tests to evidence, ready for audit.

What we cover

From strategy to validation, quality you can evidence.

01 / Strategy

Test Strategy & Planning

Risk-based test strategies that prioritise the right things, with scope, approach, entry and exit criteria, and the trade-offs made explicit.

02 / Validation

Computer System Validation

GAMP 5 risk-based validation for regulated systems. URS, FS, DS, and IQ/OQ/PQ deliverables scoped to what the regulation actually requires.

03 / Automation

Test Automation

Pipeline-integrated automated tests across web, API, and infrastructure. Frameworks chosen to fit your stack, not ours.

04 / Coaching

Quality Engineering Coaching

Skills transfer to your existing teams: test design techniques, automation patterns, and how to keep a test suite from rotting.

What you get

Test Strategy & Plans

Documents that survive their first encounter with reality, with clear ownership and review cadence.

Validation Documentation

URS, risk assessments, and IQ/OQ/PQ protocols traceable to requirements and ready for audit.

Automated Test Suites

Maintainable test code in your repository, integrated with your CI/CD, with clear conventions for your team to extend.

Quality Metrics & Dashboards

Coverage, escape rate, and lead-time-to-fix metrics that tell you whether quality is improving, not just whether tests are running.

“A highly skilled Enterprise Architect with vast knowledge, very good at solutions that fit the need, and keen that the final product can live for many years ahead.”

Rickard SpålseusSwedish Match
Let's talk

Need quality you can evidence?

Tell us what you're delivering and what you're regulated against. We'll build a quality approach that survives audit.

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