The core essence of Validation as required by the FDA is to provide documented evidence that provides a high degree of assurance that all processes, equipments, instruments, facilities, software and materials used will consistently produce a product meeting its pre-determined specifications and quality attributes. This requires establishing and updating protocols and procedures to be always consistent with the current regulations.
Xybion’s Validation Management software allows companies to create a unified process for creating, managing, and executing all validation activities across multiple sites and multiple countries and multiple regulatory guidelines as necessary.
- Risk management and predictive compliance frameworks
- Planning and scheduling
- Total inventory of all assets, policies, procedures that are subject to validation
- Create dynamic and traceable validation process steps
- Automatically create of final reports with all data automatically filled in
- Manage all validation types (Cleaning Validation, Process Validation, equipment & media qualification, etc.)
- Built-in analytics for patterns and trends
- 50%+ cost savings on average compared to existing mostly manual processes