Commissioning, Qualification and Validation
No deviation is a trusted partner for your commissioning, qualification, process performance qualification, re-qualification, and process verification since 2007.
We started providing commissioning, qualification and validation services in one of the most complex processes of the industry, which is vaccine manufacturing.
We have improved our risk-based qualification and validation capabilities, helped by the fact that we adopted the ASTM E2500 paradigm early-on. Depending on your requirements and project maturity, we could ensure a full risk-based paperless validation with integrated commissioning and test plan or make your existing paper-based IQ, OQ execution efficient.
By understanding the critical aspect of your process, No deviation will help you translate the process needs into the user requirement (URS) and functional specifications (FS), which will be a point of reference throughout the validation life cycle.
Those URS will be the source of your acceptance criteria for the systems qualification and process validation.
Starting with the design qualification (DQ) where the compliance of the design with GMP would be demonstrated and documented, as mandated in the EU GMP Annex 15.
From there, risks to the product critical quality attributes (CQA) would be assessed and we will define the testing strategy for facility and process equipment commissioning (FAT, SAT) to qualification (IQ, OQ) to process performance qualification and continuous verification.
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