BDD - A Practicable Approach for Computerised System Validation?
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Authors
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Publication date
2020
Typ of student thesis
Bachelor
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11 - Student thesis
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Hochschule für Wirtschaft FHNW
Place of publication / Event location
Olten
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wega Informatik AG, Basel
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.
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Language
German
Created during FHNW affiliation
Yes
Strategic action fields FHNW
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Review
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Citation
Leuenberger, S. (2020). BDD - A Practicable Approach for Computerised System Validation? [Hochschule für Wirtschaft FHNW]. https://irf.fhnw.ch/handle/11654/39545