VMS

The AssurX Validation Management Solution (VMS) is a software platform designed to manage the full validation lifecycle — from planning and execution through to documentation — for organizations operating under regulatory requirements. It is intended for life sciences and other regulated industries that need to eliminate paper-based processes and establish standardized, repeatable validation workflows. Clients work with AssurX validation services experts to implement the solution.

AssurX VMS incorporates quality procedures including GAMP 5 and is designed to integrate with an organization's existing SOPs, requirements, guidelines, and templates for validation deliverables. The platform also includes AutoValidator™ as part of its broader validation offerings.

Project Management and Visibility

• Provides total transparency into the status of existing and upcoming projects and validation plans.
• Presents a dynamic dashboard that displays project status in real time.
• Supports the ability to view, prioritize, and assign tasks across validation projects.
• Includes reports and charts to evaluate validation project performance.

Documentation Automation

• Automates the generation of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Automates Risk Assessments, Validation Summary Reports, Detailed Reports, and Test Protocols.

Requirement and Risk Management

• Supports defining, managing, and tracking user, functional, and design requirements throughout the software development lifecycle.
• Facilitates risk assessments and risk ranking.
• Provides a dynamic Requirement Traceability Matrix (RTM) with rapid report generation to maintain visibility between requirements and testing.

Test Management

• Provides a centralized repository for manual and automated test cases that can be shared across projects and plans.
• Includes a built-in Validation Summary Report for rapid report generation.
• Supports improved testing productivity through organized, reusable test case management.

Issue Management

• Captures and manages issues associated with validation testing through integrated workflows.
• Issues can be raised directly from within the test script.

AssurX VMS is delivered with support from AssurX's validation services team and is designed to align with established regulatory frameworks. The platform targets organizations seeking to reduce validation costs, improve quality control, and accelerate the overall validation process through standardized, auditable procedures.