How is Climedo validated?
The Climedo system is audited according to relevant standards and guidelines such as ICH GCP, GAMP5, FDA 21 CFR Part 11 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.