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How is Climedo validated?

We have followed the GAMP5 standards for the validation of the Climedo system to the best of our knowledge. The software supports our clients in getting compliant with FDA 21 CFR Part 11, Good Clinical Practice (IHC-GCP) and EU-GMP Annex 11.

Our software development process follows an agile implementation of the V-model and the GAMP5 guidelines and is validated afterwards. Our SOPs are audited by external auditors and found to be good. Validations of individual projects are carried out through User Acceptance Tests (UATs). These tests are performed together with the customer and are accepted by the customer. Climedo had the last vendor audit in 2019 for a customer in the pharmaceutical industry that confirmed this.