IQ, OQ and Qualifications
You have just received your Phileas® devices and are eager to start using them? Let Devea help you to perform Installation Qualifications (IQ) & Operational Qualifications (OQ), cycle developments and Performance Qualifications (PQ), according to GMP Annex 15. They will bring their expertise and professional support to get you started with the best protocols matching your requirements!
IQ & OQ: documents are reviewed and approved ahead of the qualifications. On the qualifications day, all parties are present to perform the tests and sign to validate each test compliance. IQ compliance leads to OQ tests. Once operational compliance is validated, performance tests can start: testing protocols with H2O2 in the room or equipment, with chemical and biological indicators to validate the efficacy. Whether you want to optimise your protocol with cycle development, or want to go straight to performance qualifications, Devea will help from protocols, test to final report signature.