Validation of Computerized Systems in GCP Environment

Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialized applications. Therefore, validation of computerized systems has become a central aspect in CRO’s daily work.

This webinar aims to give a general overview of validation procedures focusing on validation processes of non-configured (GAMP category 3) and configured (GAMP category 4) products. To illustrate this, we will play through the validation steps with the help of an example. Furthermore, we will present relevant guidelines and typical roles and responsibilities in validation and we will look at what we have learned so far from audits and inspections.