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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 VLMS Express

Simplified, cloud-based digital validation. Designed for small and mid-sized life sciences companies.

ValGenesis e-Logbook

Web-based electronic logbook software built for pharma, 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

Posts about FDA

Blog Home | Tag: FDA
February 12, 2020

FDAs Computer Software Assurance (CSA) – Part 1 of 3

With traditional CSV, too much focus is on documentation. The amount of time and effort put into documentation consumes significant resources and sacrifices critical thinking. CSA inverted this upside-down way of thinking whereby focus is placed first on critical thinking, then assurance needs, then finally testing and documentation.