Validation Management System

Total Quality and Compliance Management

Validation Management System

The essence of validation as required by the FDA is to provide documented evidence that provides a high degree of assurance that all processes, equipment, 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

Validation Management System

*Planning and scheduling

*Validation project by status

*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 and Process Validation, equipment & media qualification, etc.)

*Built-in analytics for patterns and trends

*50%+ cost savings on average compared to existing mostly manual processes.

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