Whether it is a single analytical instrument in the laboratory or a complete production line, every piece of GMP-relevant equipment must be demonstrably fit for its intended use. Our Qualification service covers the entire qualification lifecycle for lab equipment and production line equipment — from the first requirement to the final performance run.
We take over the creation of all qualification documents, starting with a clear and testable User Requirement Specification (URS), followed by Design Qualification (DQ), and the protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Every document is aligned with cGMP, EU Annex 15, FDA, EMA and ICH requirements as well as your internal Validation Master Plan and templates.
Beyond documentation, our experts also execute each qualification step on site if necessary: verifying installations against specifications, challenging operating ranges and alarm functions, handling deviations that arise during testing, and demonstrating consistent performance under real operating conditions.
By applying a risk-based approach in line with ICH Q9 and GAMP 5 principles, we focus testing effort where it matters most — on the functions that are critical to product quality and patient safety. This keeps qualification lean and efficient without ever compromising compliance or traceability.
The result is a complete, inspection-ready qualification package with full traceability from URS to PQ, allowing you to release your equipment for GMP use with confidence — on time and without surprises during audits or inspections.
Complete qualification of lab and production line equipment: we create the full documentation set — URS, DQ, IQ, OQ and PQ — and execute every step on site. Risk-based per ICH Q9 and GAMP 5, aligned with cGMP, EU Annex 15, FDA and EMA, and fully traceable from first requirement to final release.
Equipment qualification is often where projects lose time: unclear requirements, generic vendor documents and test protocols that do not survive first contact with the equipment. We prevent this by writing requirements that are specific and testable from the start, and by keeping documentation and execution in one experienced hand.
Our selected team qualifies analytical and laboratory instruments as well as complete production line equipment — filling, packaging, granulation, tableting, utilities and more. Because we both author and execute the protocols, deviations during testing are assessed and resolved quickly, the traceability matrix stays intact, and your equipment reaches GMP release without unnecessary loops.
Testable requirements from day one, documentation and execution in one hand – for lab instruments and complete production lines. Deviations resolved fast, traceability intact, GMP release without unnecessary loops.
A strong qualification begins with a strong URS. We define clear, testable user requirements for your lab or production equipment and verify in the DQ that the proposed design fully satisfies them — creating the traceable foundation for every subsequent test.
We author and execute Installation and Operational Qualification: verifying components, utilities and documentation against specifications, then challenging functions, operating ranges, alarms and interlocks — with structured handling of any deviation found during testing.
In the Performance Qualification we demonstrate consistent, reproducible performance under real operating conditions. Final reports, the completed traceability matrix and a clean handover package enable a smooth release of your equipment for routine GMP use.
We integrate seamlessly into your existing qualification framework: your Validation Master Plan, your document templates, your review and approval workflows. Where such a framework does not yet exist, we build it with you — from qualification strategy and risk assessments to protocol templates that meet current GMP, EU Annex 15, FDA, EMA and ICH expectations.
Each phase follows a disciplined sequence of planning, documented execution, deviation handling and formal reporting. This ensures full traceability from URS through DQ, IQ, OQ and PQ, and delivers a qualification package that stands up to any audit or inspection — while keeping your project timeline firmly on track.
We work within your VMP and templates or build the framework with you – planning, documented execution, deviation handling and reporting for every phase, fully traceable from URS to PQ.
Describe your project in a few sentences — a concrete proposal follows, usually within one business day.
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