Overview

Validation Centric Application Lifecycle Management (ALM)

ValGenesis 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). As a result of automating critical validation activities and eliminating the non-value added activities, ALM allows organizations to reduce the validation effort and cost by about 50%

Application changes are inevitable and unavoidable for global companies as they attempt  to meet continuous changes in process and user requirements. Validated enterprise software applications including ERP, LIMS, MES etc., need to accommodate these continuous changes while maintaining validated status.

Features

Challenges associated with maintaining the validated status of enterprise software applications:

  • Accommodating the cascading impact on validation deliverables (URS, FRS, Test Cases etc.) for a single change in any of these contents.
  • Accommodating multiple simultaneous changes in the validated system, analyzing the impact of these changes and planning required validation and/or regression testing requirements.
  • Maintaining the validated status of GAMP Category 4 and 5 systems after multiple changes is demanding.
  • Ensuring previous and current changes are documented correctly with adequate traceability is very challenging.

Since the requirements, design specifications, test cases etc. are all related; any change to one specific requirement impacts on all other associated documents and requires updating of each  associated document. This process  increases the validation effort significantly; therefore  companies must either have  large validation teams or avoid any or all of these changes in an effort  to maintain the validated status of the enterprise software application.

ValGenesis has introduced a unique, lean validation process by generating a consolidated executable Validation Summary and bringing together all the impacted items, thereby–reducing the validation effort by 50-70% –. This unique process enforces consistency, enhances efficiency and maintains validated status throughout the lifecycle of the GxP software systems with minimal effort.

 

Process

Application Lifecycle Management

Benefits

Benefits of ValGenesis Application Lifecycle Management (ALM)

  • ValGenesis Validation centric Application Lifecycle Management (ALM) creates a dynamic trace matrix between the requirements and test cases at the individual requirement and test step level.
  • ValGenesis Validation centric Application Lifecycle Management (ALM) can work with external change management systems. Further, , ValGenesis provides a comprehensive change management module with a user configurable process and workflow. The module can be effectively utilized to achieve an integrated change management process with validation deliverables.
  • True requirement based integrated validation and change management process enhances efficiency of the application lifecycle management process and reduces cycle times and efforts by 50-70%.
  • Simple selection of requirements to be changed identifies all impacted other related requirements and test cases across the system and provides an impact summary before making a change request.
  • ValGenesis Application Lifecycle Management (ALM) dynamically summarizes all impacted records into a single Change Control Validation Summary.
  • System allows users to electronically execute the Change Control Validation Summary and manage the deviations.
  • Approval of Change Control Validation Summary will meet the approval requirements for all impacted deliverables to maintain the validated status with minimal effort.
  • ValGenesis reduces the effort in maintaining the validated status of Cat 4 and 5 GxP software systems by 50-70%.
  • ValGenesis ALM provides complete visibility for the validated GxP software system across different sites.
  • ValGenesis ALM eliminates the inefficiencies inherent to managing the validated status of enterprise software applications in the manual process.
  • ValGenesis ALM enforces consistency, policies and procedures while enhancing compliance in the application lifecycle management process.
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