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 Management Services creates project deliverables that are necessary to execute a successful implementation and demonstrate an effective validation.

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Validation Management Solution

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 the performance of your validation project with powerful reports and charts.

Benefits of AssurX Validation Management Services

  • + 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.

AssurX AutoValidator™

The AssurX Validator integrates with the Validation Management Solution to automate test execution. Simplify the test management process by bundling test management and test execution to enable he deployment of high-quality applications quickly and effectively.

Working 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 Solution
  • + Reduction in Long-Term Validation Costs
  • + Streamline Validation and Qualification Activities
  • + Treat Multiple Validation Cycles Simultaneously
  • + Minimization of Compliance Risk

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

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Summary
Validation Management Solution - Quality & Regulatory Compliance - QMS | AssurX
Article Name
Validation Management Solution - Quality & Regulatory Compliance - QMS | AssurX
Description
The AssurX Validation Management Services creates project deliverables that are necessary to execute a successful implementation and demonstrate an effective validation.
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Publisher Name
AssurX, Inc.
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