Validation protocols are a method of establishing documented evidence that demonstrate a high degree of assurance that a cleanroom facility will consistently perform to the original specification in the URS, while also meeting all regulatory requirements.
In line with GMP guidance, we provide Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Perfomance Qualification (PQ) services, to support validation and quality protocols.
What is DQ IQ OQ PQ?
|Design Qualification will demonstrate and document the compliance of the design of your facility with GMP and your URS.||Installation Qualification is a documented process that ensures the facility and equipment provide exactly what is required.||Operational Qualification verifies that the installed facility and associated equipment operate in accordance with the design specifications.||Performance Qualification verifies that the facility and associated equipment operate as intended under load in accordance with the design specification in a worst case scenario.|
Connect 2 Cleanrooms integrate current applicable regulatory requirements — including the newly released EU GMP Annex 1 — and guarantee the performance of the GMP rooms based on the parameters laid out in your URS.
Through the coordination of cleanroom services and equipment, we can get your cleanroom operational faster.
Talk to the experts at Connect 2 Cleanrooms about your next project
Our cleanroom design and build specialists have experience working with customers in all kinds of industries, achieving great results time and time again. We’d love to work with you as well!
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