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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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Requirements Management

Our solutions allow users to modify, add, or delete requirements, and to route any changes throughout an approval process. With the Change Management functionality, the entire requirements change management process is maintained as a closed-loop validated process.

Products Requirements Management

Managing requirements can be both challenging and time-consuming. Requirements could be updated, modified, deleted, and/or added as the results of changes to systems and/or processes may need to be adjusted. Managing these changes to requirements poses a significant obstacle, as well as compliance risk, even when tracked via a change control process.

The problems are compounded when managing traceability matrices, where linking individual requirements to test functions and verifying appropriate testing levels are completed. The result is increased time for change approval and implementation and unnecessarily laborious project/task management.

The Requirement Management module available in ValGenesis VLMS allows our users to modify, add, or delete requirements, and to route any changes through an approval process. Once a requirement is modified, the system automatically updates the status in the traceability matrix to ensure these changes are tested. All requirement changes are automatically version controlled. With the Change Management functionality, the entire requirement change management process is maintained as a closed-loop validated process.

 
 
Requirements Management

ValGenesis Validation Lifecycle Management System Modules

Requirements 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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Webinar

How to Manage Logbooks Electronically

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Event Presentation

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

Watch

Schedule a demo

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.

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