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ValGenesis VLMS

The complete Validated Lifecycle Management System from ValGenesis is the industry-leading solution for digitizing the entire validation lifecycle.

ValGenesis e-Logbook

Web-based electronic logbook software built for pharmaceutical, biotech and other life sciences for 100% paperless logbook management.
Paperless Validation SoftwareAn overview of ValGenesis Paperless Validation Software Solutions Cleaning ValidationIntegrated, seamless lifecycle process across multiple groups and sites Commissioning Qualification ValidationRisk-based commissioning and qualification process Computer System ValidationError-free, paperless, fully automated lifecycle management process Analytical Method ValidationError-free, paperless, integrated analytical method lifecycle validation Cold Chain ValidationIoT capable validation for temperature controlled supply chains Equipment and Instruments ValidationQuick access to data and validated state of equipment Electronic Logbook ManagementVerification and review (with e-signature) of equipment logs at point-of-need Process ValidationSeamless connectivity across process, data, and knowledge management VConnectData captured from equipment is plugged into all documentation and evidence Hands-Free ValidationAugmented reality validation software for remote, hands-free validation Mobile App for ValidationOnline and offline validation process completion
Pharmaceutical and BiotechnologyAchieve standardization and data integrity via seamless processes Medical Devices and DiagnosticsSeamlessly manage DHFs across all units and sites GxP LaboratoriesEnsure data integrity and get organized with automated audit trails Blood and TissueConsistently meet Blood Establishment Computer Software (BECS) Requirements Regulated Software CompaniesQuickly release new versions/ service packs with our test automation engines Contract Research OrganizationsEnforce approved validation plans to be audit-ready without preparation NutraceuticalsSingle environment requirements management, simplifying proof of compliance
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ValGenesis Blog

The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry.

Featured Content

Digital Validation

Greenfield CDMO Theragent Sees Digitization as Key to Accelerating Innovation and Time to Market

Speed-to-market is a top priority for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.

Written by
Lisa Weeks

Computer Software Assurance (CSA)

Your Guide to Computer Software Assurance (CSA)

Is CSA the new CSV? Not exactly. Here's your comprehensive guide to computer software assurance, the FDA's new framework for validating software systems.

Written by
Lisa Weeks

Quality by Design

Apply Quality by Design (QbD) for all Validation Types - QbD for All

Watch the event presentation on the topic of Quality by Design, originally presented at Validation & GMP University in 2021.

Presented by
Steve Thompson

Trending Topics with ValGenesis Customers

CSV and the Shift to CSA

CSA flips the paradigm of validation to ensure "right sizing" of validation processes. Start preparing now.

Previously

Your Guide to Computer Software Assurance (CSA)

Computer Software Assurance (CSA): Focus on Records, Not Documentation

How Computer Software Assurance Will Impact Traditional CSV Testing

Cleaning Validation

Embrace the new generation of technology to achieve compliant, digital documentation with full integration of validation data.

Previously

Cleaning Validation Stage 2: Performance Qualification

Cleaning Validation Stage 1: On a Quest for Process Understanding

Challenges with Traditional Cleaning Validation

Transforming to Paperless

The ROI of digitization is clear: gain time efficiency, cost savings and inspection-readiness when you shift to paperless validation.

Previously

“No Paper” is Only 25% of the Benefit of “Paperless” Validation

Business Continuity Plan (BCP) for Validation Program amid a Pandemic

Paperless 3 Stage Process Validation Lifecycle Approach

Pharma 4.0

Waves of new technology and thinking — IoT, AR, cloud, agile — are transforming the very foundation of validation processes.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

How to Track Everything and Reveal Nothing: Promising Technologies to Accomplish the Impossible

Digitization of Validation for Effective Off-site Regulatory “Review” and “Inspection”

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