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Validationpreparation for GxP compliance of a Lab Information Management System
Project duration: 7 months
Brief description
To expand the market access for a successful LIMS, the manufacturer is requested to prove that the basic requirements of GxP guidelines can be fulfilled with the existing LIMS. Essentially, this means access control to result-relevant datasets, traceability of changes and the restriction of functionality to the defined processing sequences. PTA creates generic validation test cases, which are executed against defined configurations. The test run outcome is used to improve the system with respect to GxP requirements but also as a proof against the user that compliance can be achieved by configuration.
Supplement
Beside the test case creation for modules like order entry and approval, sample registration and result documentation as well as reporting a focus point of PTA´s activities is the coaching of the customers employees regarding the requirements of GxP in order to allow them to configure and adapt the LIMS accordingly. Also consulting with regards to test management and test administration and the handling within an application lifecycle management tool become part of the activities.
Subject description
Based on the regulatory constraint, the project stakeholders are aware that validation can only be executed on a final configuration by the user (final customer) instead of the manufacturer. Anyhow, very often the customer is addressing the manufacturer to declare conformity with GxP in a generic statement. To resolve this potential conflict, PTA is creating a test catalogue which allows the customer to understand the most important aspects of his configuration and to execute the validation along the given test cases.
IT project data
- Industries health care
- Specialist tasks Compliance, consulting, GxP/GMP, sample processing, test management, validation
- DP tasks quality management
- System environments organizational consulting
- Procedure model iterative procedure
- Development and test tool SpiraTeam
Project period01.01.2019 - 31.07.2019
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