As part of our Validation offerings, the AssurX Validation Management Solution and AutoValidator™ incorporate quality procedures including GAMP 5 to seamlessly integrate with your established company SOPs, requirements, guidelines and templates for validation deliverables.

Ensure The Highest Quality & Control With AssurX Validation Management Solutions

Validation of the AssurX system— regardless of configuration, risk, or complexity—is performed in a way that not only reduces time and effort but also becomes a valuable business tool. The AssurX validation services experts can evaluate business and system requirements, environment, and system architecture and create a validation package necessary to execute a successful implementation and demonstrate sufficient validation.

With the FDA’s shift to Computer Software Assurance (CSA), AssurX has developed a risk based validation model that provides customized validation services based on a critical thinking approach that supports the GAMP 5 Model. CSA encourages automated testing as well as the acceptable use of vendor documentation and formal testing of the installed software. The new approach reduces the amount of redundant documentation and validation activities, and increases the focus on ensuring the software works as intended in the installed environment.

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Risk Based Validation Management Solutions

The AssurX Validation Management Solution establishes consistent, repeatable processes for managing requirements, performing risk assessments, testing, and reporting to increase speed, improve quality, and reduce cost. Clients engage with AssurX validation services experts to implement the solution.

AssurX Validation Management Solution allows an organization to have total transparency into the status of existing or upcoming projects and validation plans. It presents a dynamic dashboard that displays status in real-time to effectively manage requirements, view, prioritize, and assign tasks and evaluate your validation project’s performance with powerful reports and charts.

Benefits of the AssurX Validation Management Solution

  • + Automate Technical and Validation Documentation:
  • Automate User Requirement Specifications, Functional Requirement Specification, Risk Assessments, Validation Summary, and Detailed Reports and Test Protocols.
  • + Requirement and Risk Management:
  • Define, manage, and track user/functional/design requirements through the software development lifecycle. Perform risk assessments to facilitate effortless risk ranking.
  • + Requirement Traceability Matrix:
  • Dynamic traceability matrix and rapid report generation of the Requirement Traceability Matrix (RTM) to increase visibility between requirements and testing during the software development lifecycle.
  • + Test Management:
  • Improve testing productivity and create a centralized repository of manual and automated test cases that can be shared across projects and plans. Includes a built-in Validation Summary Report for rapid report generation.
  • + Issue Management:
  • Comprehensive issue management capabilities capture and manage issues associated with validation testing through integrated workflows — directly from the test script.

Automate Test Execution with the AssurX AutoValidator™

The AssurX AutoValidator™ integrates with the Validation Management Solution to automate test execution. Simplify the test management process by bundling test management and test execution to quickly and effectively deploy high-quality applications.

In conjunction, the two solutions provide the ability to create a paperless quality process that allows for repeatable requirement gathering, validation planning, scheduling tests, analyzing results, and managing configuration issues.

AssurX Validation Management Solutions Infograpghic
  • + Reduction in Long-Term Validation Costs
  • + Streamline Validation and Qualification Activities
  • + Greater Insights into the Application Lifecycle
  • + Treat Multiple Validation Cycles Simultaneously
  • + Minimization of Compliance Risk

The AssurX Validation Management Solution and the AutoValidator™ contour with any validation framework to conduct manual and automated testing, complete requirement traceability, increase visibility on configuration issues, and generate validation reports.

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