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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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Content Lifecycle Management

ValGenesis VLMS reduces content generation cycles while enforcing compliance, assuring consistency, data integrity, and auditable audit trails.

Products Content Lifecycle Management

ValGenesis VLMS is a comprehensive SaaS-based tool to visualize and manage requirements, test cases, and audit trails across your validation processes.

Compatible with Word and Excel – Minimal training needed for those already familiar with MS Office

Audit Trails – fully compliant audit trails are maintained and readily available for review during an audit or inspection

Reusable Content Library – Use pre-approved validation elements (test cases, requirements, terms, definitions, etc.) for a specific purpose or across multiple documents sites or enterprise-wide. This drives down content authoring by over 50% while improving consistency

Efficient Template Creating and Management – Create templates from existing MS Word or Excel documents to save time and assure consistency. Template revision management guarantees users only access approved templates; legacy templates can be deactivated or terminated

Real-Time Track Changes – Reviewers can see changes by others delivering real-time collaboration. Review duplication and multiple version conflicts are eliminated

Protect Content – Protect templates, test cases or other content to reduce review and approval cycles while improving consistency

Collaborative Workflow – with collaborative workflow processes, key stakeholders can review and approve documents through serial, parallel, or hybrid routing, controlling who is authorized, the reason for signatures, with extensive tracking
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ValGenesis Validation Lifecycle Management System Modules

Content Lifecycle Management is a fully integrated module for ValGenesis VLMS, the most complete digital validation system.

Validation Plan and FrameworkMaintain a consistent approach across all validation processes and sites
Content Lifecycle ManagementTrack documentation from design to change management and validation
Risk-Based ValidationEvaluate and control risk at functional and/or system levels
Electronic Test Case ExecutionExecute test cases quickly and securely, anywhere at any time
GxP Asset ManagementManage the lifecycle of GxP assets with a documented audit trail
Validation ProjectsManage complex validation projects with required quality gate checks
Periodic Review ManagementIdentify and manage the review schedules of validated GxP systems
Robotic Test Case ExecutionReduce execution time by up to 90% by removing human errors
Change Control and ManagementTrack and efficiently manage any type of change request
Dynamic Trace MatrixIdentify and fix defects related to important requirements
Requirements ManagementManage change requirements as a closed loop validation process
Retirement and Decommissioning ProcessPlan and execute the entire process with required quality gate checks
Equipment Log ManagementRecord, verify, and review logs as per approved SOPs/standards
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White Paper

ValGenesis VLMS Compliance Assessment - USFDA Data Integrity Guidance

Read
Event Presentation

Ensure Data Integrity by Design (DIbD) - The Right Data, Right from the Start

Watch

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Reach out to schedule a free, personal demo of the ValGenesis VLMS. We’ll show you our product in-depth and share our experience to identify the perfect solution for your organization.

Schedule a Demo