ValGenesis’s Application Lifecycle Management (ALM) is the only lifecycle management solution designed specifically to validate and maintain the validated status of complex software applications (GAMP 5 Cat 4 and Cat 5). By automating critical validation activities and eliminating the non-value-added activities, our ALM allows organizations to reduce both validation effort and costs. Application changes are inevitable and unavoidable for global companies that must continuously manage regular changes in process and user requirements. Validated enterprise software applications including ERP, LIMS, MES, etc. must be able to accommodate such changes while still maintaining validated status.

The ValGenesis ALM provides our clients with a number of significant advantages and benefits:

Creates a dynamic trace matrix between requirements and test cases at both the individual requirement and test step level

Capable of working with external change management systems

Requirement-based, integrated validation and change management process enhances efficiency of the lifecycle management process and reduces cycle times

Simple selection of changes identifies all requirements and test cases across the system and provides an impact summary before making a change request

Dynamically summarizes all impacted records into a single Change Control Validation Summary

Users can electronically execute the Change Control Validation Summary and manage deviations

Change Control Validation Summary approval meets requirements for all impacted deliverables, maintaining the validated status with minimal effort

Reduces effort in maintaining the validated status of Cat 4 and 5 GxP software systems

Provides complete visibility for the validated GxP software system across different sites

Eliminates many of the inefficiencies that are inherent in managing validation of enterprise software applications

Enforces consistency, policies, and procedures while enhancing compliance in the ALM process



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