Companies within the regulated pharmaceutical industries are facing trends such as globalization, cloud, rising production costs and skills shortages, just like all other industries.
A key success factor for this is a software system that naturally meets the requirements of GMP and computer-aided validation and provides significant support in the tasks of safeguarding, implementation and documentation. Workflow-supported processes control and document GxP-relevant processes along the entire value chain.
In addition, efficient and risk-based validation must be ensured for updates and upgrades of the systems. Extensively documented update packages including GxP criticality and test evidence stand for reliable and uninterrupted productive use to minimize or even eliminate any disruptions to ongoing operations.
In this webinar, we present our GUS-OS system and its update capability in the context of risk-based validation. Our software and validation experts will present both the concepts and a short showcase demonstrating how to minimize correct validation while ensuring CSV requirements are met.
This combination of technology and risk-based approach significantly reduces validation efforts during the entire lifecycle of an ERP system, which in German-speaking countries is approximately 10-12 years long.
FOCAL POINTS AT A GLANCE
- Introduction to process-driven work
- Controlled, efficient documentation
- Coordination of employees and tasks
- Safeguarding in the QM system
- Structure and procedure of the update packages
YOUR VALUET
- Support through workflow-driven work
- Insight into low-effort updates and upgrades
- Reduction of administrative effort and transparency in processes
