BDD - A Practicable Approach for Computerised System Validation?
Increased automation for Computer System Validation (CSV) in the pharmaceutical Industry is one step closer to reality: Behaviour Driven Developement (BDD) enables GxP compliant automated validation!
Leuenberger Sabrina, 2020
Bachelor Thesis, wega Informatik AG
Betreuende Dozierende: Stephan Jüngling
Keywords: Computerised System Validation (CSV), Behaviour Driven Developement (BDD), GAMP5, GxP Compliance, OQ Test Automation, Pharma, Cucumber, Gherkin, Scenarioo, Cucumber-Scenarioo-Plugin
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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.
Three steps were taken to achieve this goal:
1. Development of an OQ process containing the BDD practices to perform automated OQ.
2. Implementation of this process by means of a prototype to check its feasibility.
3. Audit of the prototype by an experienced CSV expert to assess the GxP suitability of the process.
As it turned out, it was indeed possible to develop a process with automated OQs and implement a GxP-compliant prototype based on it. This could open new possibilities for software validation, e.g. in the context of a digital transformation strategy.
Studiengang: Wirtschaftsinformatik (Bachelor)
Fachbereich der Arbeit: Wirtschaftsinformatik & IT-Management
Art der Arbeit
wega Informatik AG, Basel
Autorinnen und Autoren
Sprache der Arbeit
Computerised System Validation (CSV), Behaviour Driven Developement (BDD), GAMP5, GxP Compliance, OQ Test Automation, Pharma, Cucumber, Gherkin, Scenarioo, Cucumber-Scenarioo-Plugin