Expertise
A lab or a piece of equipment is only as good as its qualification. We take facilities and equipment through design, qualification and validation, so what you build holds up under audit.
From laboratory design through to full equipment qualification engineering, URS, IQ, OQ and PQ, and eventually decommissioning, we cover the qualification lifecycle end to end, including commissioning and qualification (C&Q, IOC) work and qualification strategies for automated systems.
We also write the validation protocols and reports that go with it, so the qualification work is documented in a way that survives an audit, not just a way that got the system running.
Functional requirements, regulatory requirements, future scalability.
Laboratory layout, personnel and material flows, HVAC systems, water systems.
Design, Installation, Operational and Performance Qualification (DQ/IQ/OQ/PQ).
Laboratory instrumentation, critical support systems, computerised systems.
Readiness assessments, qualification programme execution, operational handover.
Qualification is widely assumed to start once equipment is installed; in reality it starts at conceptual design, where the decisions with the biggest impact on compliance, operability and cost get made, and labs built around today's needs alone tend to outgrow themselves fast.
We support new builds, renovations and relocations, and each calls for a different focus.
A new build is about getting the conceptual design, future scalability and regulatory-by-design principles right from the start.
A renovation, usually the hardest of the three since operations have to continue through it, is about operational continuity, contamination control and a phased qualification strategy.
A relocation centres on business continuity, requalifying equipment, and proving method and process comparability alongside the regulatory impact assessment.
Usually project-based, run alongside your engineering and quality teams so the qualification approach stays usable after the project ends.
Tell us what you're working on, we'll get back to you with a plan that fits.
