A Case Study of Continuous Monitoring of SAP Pharma Validation
In this example of SAP Pharma Validation, our client is a global pioneer in pharmaceuticals and diagnostics, committed to advancing science to improve people’s lives. Their operational excellence relies heavily on robust ERP systems, particularly SAP, for managing production logistics worldwide.
Challenge: Ensuring Continuous Validation of SAP ERP System for Efficient Production Logistics
The challenge in this Sap Validation in Pharma Case Study was to ensure continuous validation of the ERP system, crucial for overseeing the production process logistics. This involved monitoring and evaluating the documentation changes and testing processes rigorously. The validation process needed to verify the correctness and validity of all changes made, ensuring seamless integration into the testing environment.
Solution: Comprehensive Validation Management for Global ERP Systems
Our team undertook responsibility for the validation process within our client’s global ERP system. Key activities included:
- Continuous oversight of the change process within the system.
- Evaluation of the scope of documentation changes and testing for each modification.
- Assessment of the correctness and validity of documentation changes.
- Validation of executed tests.
- Implementation of changes into the testing environment.
This meticulous process described in this SAP Pharma Validation example was managed by a dedicated team of four experts, ensuring comprehensive oversight from 9 AM to 10 PM to accommodate global operations.
Outcome: Significant Error Reduction and Process Improvement
During operational work, we identified opportunities to enhance processes in this Case study of SAP Pharma Validation, exemplified by introducing a process to register documentation and testing imperfections. Personnel were trained to eliminate causes of imperfections, and authors of errors underwent a quick assessment survey to identify training deficiencies. Within a quarter, the number of errors decreased by 75%.
Conclusion: Optimizing Pharma ERP Systems for Better Patient Safety and Product Integrity
From the client’s perspective, our extensive experience in validation and optimization of quality processes based on lean techniques proved invaluable. Our deep understanding of pharmaceutical processes enabled us to comprehend client needs and effectively address risks related to patient safety, product integrity, and regulatory compliance.
This Pharma SAP Validation Case Study exemplifies our commitment to ensuring the reliability and efficiency of ERP systems critical to the pharmaceutical industry, underscoring our role in supporting global healthcare advancements through meticulous validation and process optimization.
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