BDD - A Practicable Approach for Computerised System Validation?

Abstract

Computer systems in the highly regulated GxP environment of the pharmaceutical industry must be validated. One aspect of validation is the verification process, which includes the verification of the functional specifications (OQ). Even today, this process is still mostly done manually and is therefore time-consuming and error-prone. Therefore, the aim of this thesis was to examine whether automation of OQ could be implemented in a compliant way. For this purpose, the BDD approach was used, as it employs practices and tools that enable automated high-level testing.