GxP-PROOF MES HARMONIZATION
SUCCESS STORY Data Integrity and Validation of an MES System.
Creating a new MES landscape for a research-based pharmaceutical and biotech company.
Expertise
#GxP-Compliance
#Data Integrity in Manufacturing
#1 CHALLENGE
Harmonized Manufacturing Execution System (MES) and reporting standards are essential for effective communication between stakeholders, such as suppliers and manufacturers, and help reduce the risk of errors when integrating production sites into corporate systems.
Our client, the manufacturing site of a global pharmaceutical company, planned to harmonize its production reporting as part of the realignment of its MES landscape. A key element was the introduction of a centralized reporting and data visualization tool that provides a unified overview of all sites.
#2 APPROACH
msg industry advisors supported the reorganization of the client's MES landscape on multiple levels: This included both ensuring data integrity and the proper planning and execution of (computer) system validation.
To this end, the project team, together with the client, developed the central validation plan and system documentation. In parallel, experts from msg industry advisors contributed to the content of the data integrity concept, ensuring that requirements for long-term data retention, as well as the implications of data compression and complex system interfaces, were appropriately addressed.
#3 OUTCOME
By introducing a centralized reporting and data visualization tool, the client established the foundation for increased transparency and improved collaboration within production processes. The close support provided by msg industry advisors ensured GxP-compliant operation of the application and a go-live on schedule.
Thoughtful planning enabled a structured approach and pragmatic decision-making. The targeted use of appropriate tools increased efficiency and prevented friction losses, which accelerated implementation and ensured high quality. Early and transparent communication enabled the active involvement of all stakeholders and clear alignment of expectations.
#4 OUR IMPACT
Why msg industry advisors make the difference:
- Active and systematic support of the changes through early involvement of relevant stakeholders and use of quick wins
- Significant reduction in testing efforts through our practice-proven approach for the systematic identification, assessment, and management of data integrity risks
- In-depth experience gained from the execution of numerous data integrity projects on a global scale in the pharmaceutical industry
Key Facts:
4 Experts
16-month project duration
>20 Workshops
#1 CHALLENGE
Harmonized Manufacturing Execution System (MES) and reporting standards are essential for effective communication between stakeholders, such as suppliers and manufacturers, and help reduce the risk of errors when integrating production sites into corporate systems.
Our client, the manufacturing site of a global pharmaceutical company, planned to harmonize its production reporting as part of the realignment of its MES landscape. A key element was the introduction of a centralized reporting and data visualization tool that provides a unified overview of all sites.
#2 APPROACH
msg industry advisors supported the reorganization of the client's MES landscape on multiple levels: This included both ensuring data integrity and the proper planning and execution of (computer) system validation.
To this end, the project team, together with the client, developed the central validation plan and system documentation. In parallel, experts from msg industry advisors contributed to the content of the data integrity concept, ensuring that requirements for long-term data retention, as well as the implications of data compression and complex system interfaces, were appropriately addressed.
#3 OUTCOME
By introducing a centralized reporting and data visualization tool, the client established the foundation for increased transparency and improved collaboration within production processes. The close support provided by msg industry advisors ensured GxP-compliant operation of the application and a go-live on schedule.
Thoughtful planning enabled a structured approach and pragmatic decision-making. The targeted use of appropriate tools increased efficiency and prevented friction losses, which accelerated implementation and ensured high quality. Early and transparent communication enabled the active involvement of all stakeholders and clear alignment of expectations.
#4 OUR IMPACT
Why msg industry advisors make the difference:
- Active and systematic support of the changes through early involvement of relevant stakeholders and use of quick wins
- Significant reduction in testing efforts through our practice-proven approach for the systematic identification, assessment, and management of data integrity risks
- In-depth experience gained from the execution of numerous data integrity projects on a global scale in the pharmaceutical industry
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