Qualification and documentation that grow with the project.
Execution of DQ/IQ/OQ/PQ — with end-to-end traceability and audit-ready documentation in GMP-regulated project environments.
Qualification & documentation ties requirements, design documents, testing and evidence together.
It keeps documentation moving with the project instead of leaving it until the end — from the URS through to an audit-ready handover.
From requirement to handover.
We come in at URS and basic design where possible. That way the chain of requirements and evidence builds with the project rather than being reconstructed at the end.
What we take on.
Requirements & traceability
We keep requirements traceable — from the URS through design to test. Every requirement ends up with its evidence.
Testing & qualification (DQ/IQ/OQ/PQ)
We structure testing and evidence — from test scope through acceptance criteria to the signed-off record.
Documentation & handover
We keep documentation audit-ready and fit for handover — structured, complete, traceable.
One unbroken evidence trail.
Every requirement from the URS stays linked through to its evidence — complete and checkable. Audit readiness builds with the project, not at the end of it.
Row labels (U-01 …) are neutral placeholders.
Documentation that keeps up, not catches up.
01Documentation grows with the project.
Requirements, testing and evidence develop in parallel — not retrospectively at the end of the project.
02Traceability end to end.
From the URS through design and the list of tests to the DQ/IQ/OQ/PQ record, every step stays linked.
03Experienced in the role.
As qualification manager and validation manager we steer qualification and validation across the whole project.
04Audit-ready, without gaps.
Structured document sets and traceable evidence hold up under inspection.
We work in GMP-regulated project environments and follow established standards and guidance — among them EU GMP Annex 15 and GAMP 5. We also work with software and system tools we have purpose-built for this way of running projects. We are not a certified testing or qualification body and we issue no certificates. We support your project team in working to these standards and producing audit-ready evidence.
Common questions.
Are you a certified testing or qualification body?
No. We issue no certificates and are neither a notified nor an accredited body. We support your project team with qualification, validation and documentation, working to the relevant standards and guidance.
Which standards and guidance do you work to?
We follow EU GMP Annex 15 and — for computerised systems — GAMP 5. Your own company requirements and SOPs remain authoritative.
When in the project should qualification be brought in?
Ideally from the URS or basic design onwards. The earlier requirements, specifications and test scopes are linked, the more robust the later evidence — and the less has to be reconstructed at the end of the project. We ramp up our involvement to match what your project actually needs.
Do you also take on individual scopes — the OQ documentation alone, say?
Yes. We support either continuously across the whole project or selectively — a single qualification stage, the traceability matrix, or pulling handover documentation into shape.
How do you make sure it stands up to an audit?
Through an unbroken evidence trail: every requirement stays linked and referenced from the URS through testing to its evidence. Documents are kept structured, versioned and ready for handover.
Your contact for qualification.
Responsible for the technical delivery of complex plants in pharmaceutical and food environments — from test planning through to qualified handover.
olaf.gasch@ecc-process.comEnquire about a project.
Tell us briefly about the plant, the project phase and the evidence you need — we will come back with the next step.
Enquire about a project or directly: kontakt@group-ecc.com