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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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Electronic Test Case Execution

ValGenesis electronic test case execution functions execute test cases faster and more securely, anywhere at any time, to accelerate validation processes. Illegible handwriting is a thing of the past. Content is electronically and directly input to the test cases being executed.

Products Electronic Test Case Execution

In a paper-based validation environment, there are many challenges and compliance risks related to executing validation protocols-illegible handwriting, spelling mistakes, missing signatures and lack of associated objective evidence(attachments, screenshots, etc.). A much more troubling issue in paper-based execution is the potential for lost, stolen and/or destroyed documents. In addition to these issues, as with any paper document that requires approval, the processing time for review/approval is inefficient and constrained by the need for manual tasks such as faxing, printing, scanning and mailing of validation documents.

With our electronic test case execution functions, illegible handwriting is a thing of the past. Content is electronically and directly input to the document being executed. Also, a spellcheck function allows users to review their work for spelling errors before submission. Adding screenshots or file attachments to any executed row can be achieved with a few simple mouse clicks. Electronic signatures are automatically added for any user performing an execution, along with date/time stamps for all rows of a test case. Loss and/or physical theft of documents is impossible with our centrally managed electronic system. Furthermore, review/approval processes are significantly accelerated since all documents are electronically routed to their assigned reviewers/approvers, in real-time and regardless of geographic location. Test cases can be executed either with a laptop or any tablet device, with or without a network/internet connection.
Electronic Test Case Execution
Electronic Test Case Execution
The Electronic Test Case Execution workflow.

ValGenesis Validation Lifecycle Management System Modules

Electronic Test Case Execution 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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Event Presentation

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

Watch
White Paper

ValGenesis VLMS Compliance Assessment - FDA 21 CFR Part II

Read

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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.

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