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Product Datasheet: VAL

VAL™ AI-Powered Validation Assistant for faster, more consistent validation

See how VAL™ automates validation document generation and execution while supporting regulatory requirements, so teams can move faster with fewer manual steps.

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What’s in it

This datasheet explains how VAL™ automates protocol creation, data entry, and validation execution, including AI-based recommendations for Pass/Fail/NA and real-time evidence collection and verification. It outlines tools for checking executed results against expected outcomes, flagging anomalies, and reviewing attachments for compliance. You’ll also find capabilities for identifying missing requirements, mapping URS, DS, and FRS to test cases to spot coverage gaps, and monitoring documents for GDP violations based on approved SOPs.

The document includes scalability details for multisite use and cloud hosting options, plus technical and security specifications such as role-based access control, encryption, ISO 27001:2013 certification, and disaster recovery and backups.

Who is this for

  • Validation managers and CQV/CSV leads responsible for protocol authoring and execution oversight
  • Quality assurance leaders focused on inspection readiness and controlled documentation
  • Regulatory compliance teams reviewing Part 11 expectations and audit evidence practices
  • Manufacturing engineering and operations leaders trying to reduce validation cycle time and rework
  • IT and digital quality teams responsible for access controls, security, and scalable deployments

What it helps with

  • Reduces validation document generation time by up to 80% through automated protocol creation
  • Cuts manual data entry and test-step execution time by up to 70% with automated execution support
  • Improves consistency in protocol grammar, formatting, and structure across sites
  • Flags anomalies and inconsistencies in real time to avoid late rework and delays
  • Finds missing requirements and traceability gaps by mapping URS, DS, and FRS to test cases
  • Supports regulatory requirements (including FDA 21 CFR Part 11, EMA, and GAMP 5) with built-in compliance enforcement
  • Supports secure handling of validation data with RBAC, encryption, ISO 27001:2013 controls, and disaster recovery/backup systems