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AssurX Validation Management Solution

A system to manage validation processes, ensuring compliance and standardization, with real-time project tracking and automated documentation.

Solution by AssurX
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Overview

The AssurX Validation Management Solution (VMS) is designed to streamline validation processes by eliminating paper-based methods and enforcing standardization and compliance. It establishes consistent, repeatable processes for managing requirements, conducting risk assessments, testing, and reporting. This approach enhances speed, quality, and cost-efficiency. Organizations can engage with AssurX validation experts to implement this solution effectively.

VMS provides complete transparency into the status of current or upcoming projects and validation plans through a dynamic dashboard. This dashboard offers real-time status updates, enabling effective management of requirements, task prioritization, assignment, and performance evaluation of validation projects using comprehensive reports and charts.

The solution integrates seamlessly with existing company SOPs, requirements, guidelines, and templates for validation deliverables, incorporating quality procedures such as GAMP 5. It includes the AutoValidator™ to further enhance integration.

Benefits of the AssurX Validation Management Solution

  • Built-in Dashboards & Analytics: Visually capture every stage of the validation process quickly and easily.
  • Project Management: Offers total transparency into project statuses and validation plans with real-time dashboards for effective task management and performance evaluation.
  • Automate Technical and Validation Documentation: Automates the creation of User Requirement Specifications, Functional Requirement Specifications, Risk Assessments, Validation Summaries, Detailed Reports, and Test Protocols.
  • Requirement and Risk Management: Define, manage, and track requirements throughout the software development lifecycle, facilitating effortless risk ranking.
  • Requirement Traceability Matrix: Provides a dynamic traceability matrix and rapid report generation to enhance visibility between requirements and testing.
  • Test Management: Centralizes manual and automated test cases, improving testing productivity and includes a built-in Validation Summary Report for quick report generation.
  • Issue Management: Captures and manages issues associated with validation testing through integrated workflows directly from test scripts.

Overall, the AssurX VMS saves valuable time and accelerates the validation process, ensuring high-quality outcomes and control.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management