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ValGenesis

AI-Powered Digitalization for Life Sciences.

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Overview

ValGenesis provides an AI-enabled digital validation platform called Smart GxP™, designed to unify development, commissioning, qualification, validation, and continued process verification for life sciences companies. It offers a suite of integrated applications to manage the entire validation lifecycle, from early-stage process development to commercial manufacturing. The platform aims to eliminate paper-based validation processes, ensure compliance, and accelerate time to market.

✨ Key Features

  • AI-enabled digital validation platform (Smart GxP™)
  • Validation Lifecycle Management System (VLMS®)
  • Paperless validation and electronic logbooks
  • Continued Process Verification (CPV)
  • Cleaning validation management
  • Equipment and instrument validation
  • Quality risk management
  • Compliance with 21 CFR Part 11 and Annex 11

🎯 Key Differentiators

  • Pioneer in paperless validation lifecycle management
  • AI-enabled platform for smarter validation
  • Comprehensive suite of applications covering the entire product lifecycle

Unique Value: ValGenesis enables life sciences companies to achieve digital transformation of their validation processes, resulting in significant efficiency gains, improved compliance, and faster time to market.

🎯 Use Cases (5)

Digitizing and automating validation processes Managing the entire validation lifecycle for drugs and medical devices Ensuring compliance with regulatory requirements Streamlining tech transfer and process development Real-time monitoring of manufacturing processes

✅ Best For

  • Used by 30 of the top 50 global life science companies.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • NA

🏆 Alternatives

MasterControl Veeva Systems Kneat

Compared to manual, paper-based validation processes, ValGenesis offers a fully digital, automated, and integrated solution that provides a single source of truth for all validation activities.

💻 Platforms

Web

🔌 Integrations

ERP systems QMS systems LIMS API

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (NA tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ EU Annex 11

💰 Pricing

Contact for pricing

Free tier: NA

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