About the client
A multinational, biotech company and a leading provider of cancer treatments globally. The company specializes in in-vitro diagnostics and in the supply of transformative and innovative solutions across major disease areas.
The challenge
The client needed support with the quality assurance process as part of the development and implementation of the FTPS system. It is a Manufacturing Execution System implemented as a layer between the pharmaceutical manufacturing equipment control systems and the SAP ERP, used for manufacturing drug products in solid or liquid production, packaging and diagnostics.
What we did
- Analyzed the business process of the MES-related implementation.
- Provided requirement analysis, and testing management (test definition and execution).
- Performed SAT, UAT and Regression testing (formal release validation) for PharmaSuite functionalities using the ALM Pharma tool.
- Connected testing activities like interface testing for external systems (SAP, TIBCO/MuleSoft, SCC, PMX, LIMS, EWM, WH), WIKI Knowledge base management, and Incident Management process support.
- Created a standardised solution for all the client’s sites as part of the Global Recipe Solution and process harmonization.
Benefits for the client
Taking responsibility for the quality of the entire system in the context of:
- Ad-hoc tests for the Test Preparation and Dry Run phases for each release
- Exploratory and E2E Interface tests before and during the release
- System Acceptance Tests according to User Requirements and Functional specifications
- User Acceptance Tests according to User Requirements to reflect the E2E business process
- Regression tests for the critical business functionalities
- Maintenance and management of domain knowledge
