Validation Lifecycle Management System

ValGenesis VLMS is the industry standard digital validation platform for life sciences worldwide. Peerless in capability, it empowers you to enforce standardization, ensure data integrity, reduce risk, lower the cost of quality, and strengthen your compliance posture.

The Most Complete Validation System

  • Single source of truth across your GMP operation with a holistic view of the entire validation lifecycle
  • Highly configurable with module-based deployment
  • Multi-site scalability, multi-lingual ready
  • Delivers increased speed and efficiency to every validation activity

Ready for Every Validation Process

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CQV

Meet cGMP requirements and maintain a state of continuous compliance.

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CSV and CSA

Apply a risk-based approach and reduce overtesting for shorter cycle times.

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Equipment

Guarantee the accuracy and auditability of your equipment and instruments.

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Process

Eliminate silos with seamless connectivity across process, data, and knowledge management.

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Method

Prove your analytical methods are robust, reproducible, and fit for their intended use.

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Cleaning

Establish controls and reduce error and risk at each stage of the cleaning process.

Establish Control and Minimize Risk

Leverage a single source of truth for all validation activities and supporting documentation

  • Apply a risk-based approach with assessments at the requirement, functional, or system level to determine the proper level of validation required
  • Enforce standardized protocol templates and testing requirements based on the risk profile
  • Automate authoring with decision tree assessments
  • Support any change control process workflow by change type through process maps
  • Eliminate guesswork with dynamically updated traceability matrices

Enforce standardization and achieve consistent documentation with a risk-based approach.

Accelerate Productivity

Introduce critical thinking into your validation plan for faster, more confident decision-making

  • Employ a least burdensome approach, focusing your testing on mid- to high-risk requirements
  • Divide and conquer with online collaboration and split execution
  • Implement agile, waterfall, linear, or other validation methods as your business requires
  • Integrate with third-party applications to streamline development, testing, and business operations

Focus on testing high-risk requirements for maximum efficiency.

Build Your Case for Quality

Implement high-quality processes that lead to high-quality products, reducing your risk of defects or recalls

  • Improve regulatory compliance by executing quality processes
  • Facilitate quality by review (QbR) with standardization, preapproved workflows, and easily accessible audit trail metadata
  • Eliminate subjectivity with controlled processes, configurable risk models, and standardized validation deliverables
  • Create and enforce technical controls to minimize inconsistencies and human error

Establish business rules to assess your risk score and invoke process conditions.

Always Be Improving

Monitor changes to systems and validation deliverables to identify problematic systems and areas for improvement

  • Capture data for business intelligence and analytics
  • Generate reports and export data for time-motion analysis
  • Create dashboards and metrics to keep your finger on the pulse of validation
  • Continuously assess the status of a system's validated state through periodic reviews
  • Establish a data lake as a source for artificial intelligence (AI) and machine learning (ML)

Drill down to real-time validation details for the entire system in just a few clicks.

What's New in VLMS v4.2?

New: Design Manager Module

  • First-to-market CSA-ready solution, providing risk assessment at the requirement level to reduce overtesting common in CSV.
  • Supports agile methodology with backlog, sprint, testing, and release management.
  • Unifies validation data into a single source of truth that aligns validation and development cycles to follow the SOPs of SDLC.

  • Read the press release.

Execution With PDF Documents

In addition to executing protocols developed in Word or Excel, you can now execute protocols in PDF format.

P&ID Support

Upload piping and instrumentation diagrams (P&IDs), map P&ID locations during authoring, and leverage P&ID files as objective evidence.

e-Logbook Integration

Seamlessly navigate between VLMS and e-Logbook and pull entities created in VLMS for log capture.

ValGenesis VLMS Drives Leaps in Productivity

40%
Faster

Authoring, executing, and approving validation protocols

50%
Faster

Creating and maintaining traceability matrices

50%
Faster

Performing, reviewing, and approving risk assessments

80%
Faster

Tracking validation status

90%
Faster

Preparing for audits and inspections

These values are based on real-world ROI studies of ValGenesis VLMS customers. Download the e-book "How to Calculate the ROI of Digitized Validation" for more details.

And Real Benefits Across the GxP Organization

Persona - Validation Engineer

Validation Teams

  • Apply agile methodologies to validation
  • Asses risk at the requirements level
  • Enforce consistent results
  • Capture objective evidence directly in the protocol
  • Speed approvals with automated routing and GxP-compliant e-signatures
  • Manage test failures via predefined workflows
  • Produce clear, precise time-stamped audit trails
Persona - Quality

Quality Teams

  • Enforce correct template usage — every time, at all sites
  • Avoid tedious recreations of requirements traceability matrices
  • Ensure ALCOA+ data integrity
  • Deploy technical controls to enforce SOPs
  • Eliminate illegible handwriting and encourage GDocP
  • Initiate and perform quality by review (QbR)
Persona - IT

IT Teams

  • Cut system management burden with a cloud-based system
  • Standardize all validation activities with a unified platform
  • Keep information and processes secure
  • Implement your backup, disaster recovery, and business continuity plans
  • Extend your single sign-on (SSO) identity management system
  • Perform forensic analysis of data
Persona - Exec

Executives

  • Avoid observations, warning letters, and consent decrees
  • Reallocate staff time and budget to value-added activities
  • Get to market faster by reducing validation cycles by > 50%
  • Attract a modern workforce with best-in-class digital tools
  • Rest assured that regulatory requirements are  adhered to

Learn More From Our Experts

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Blog Post

Electronic Logbook Management

Should eLogbook Software Work Offline? Yes, Here's Why.

Read the Blog Post


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Industry Insight

The Shift from CSV to CSA

Read the Article


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Webinar

Unveiling Key Strategies for Optimizing Quality Risk Management

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See how ValGenesis can support your digital transformation.