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Validation of a laboratory information system

Project duration: 6 months

Brief description

While releasing a laboratory information system's microbiology module as a global product, the module is validated in accordance with ISO 13485. The complete documentation of the module is created and all functions are verified. The system test comprises approximately 220 screens and approximately 1500 PL/SQL functions: a total of 800 test cases with approximately 1000 tests.


The basis for the test documentation is an Enterprise Architect (EA) model which records each function as a use case. The test cases are linked to these use cases and the tests are created in EA. The EA reporting functions use this model to create the test documents.

Subject description

ISO 13485 defines the requirements for quality management of medical products and the requirements for regulatory purposes. This ISO norm is required in order to market a laboratory information system.


Project period01.01.2006 - 30.06.2006

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