Qualification & validation

To ensure the reproducibility of your manufacturing processes and thus the production quality and ultimately the ongoing product quality, we take on the qualification of equipment and systems as well as the validation of established methods and processes - right up to the software validation of computerized systems in accordance with Good Automated Manufacturing Practice - cGAMP.

We carry out all qualification steps for our customers, such as the design, installation, functional and performance qualification (DQ, IQ, OQ, PQ) of technical equipment and entire production facilities in accordance with the applicable GMP guidelines (Annex 15 of the EU GMP guidelines, ICH Q9, AMWHV and other guidelines including the ISO 13485 standard and other specific standards for medical devices). And we validate the associated processes and procedures, including software validation (Computerized Systems Validation; CSV), to ensure that our customers' workflows reproducibly lead to the desired result.

In line with lean principles and consistent quality risk management, we carry out risk analyses in advance to identify critical factors to which we pay particular attention. We are familiar with the necessary technical and (if required) analytical test methods and prepare GMP or standard-compliant documentation of our results for your QM system.