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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 Process ValidationSeamless connectivity across process, data, and knowledge management Electronic Logbook ManagementVerification and review (with e-signature) of equipment logs at point-of-need ComplianceSolutions designed to facilitate compliance with all industry standards and regulations VConnectData captured from equipment is plugged into all documentation and evidence
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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Validation Plan and Framework

To enforce consistent execution of the Validation Plan, ValGenesis VLMS is designed with a Validation Framework function that allows users to define validation standards and deliverable requirements that can be applied to one or more GxP systems.

Products Validation Plan and Framework
Validation Plan and Framework

For any manufacturing enterprise operating in the regulated life sciences environment, one of the biggest challenges is maintaining a consistent approach across different validation processes and sites. Consistency is a key factor in any validation process and a crucial part of the criteria by which regulators measure the reliability of any validation process. To enforce consistent execution of the Validation Plan, ValGenesis VLMS is designed with a Validation Framework function that allows users to define validation standards and deliverable requirements that can be applied to one or more GxP systems.

Our Validation Framework function provides a mechanism for enforcing consistency and compliance across all types of validation processes:

Complete visibility with real-time validation status for GxP assets and processes

Define required validation deliverables at the individual asset level or grouped assets level

Define and enforce validation / qualification requirements at the asset level or grouped assets level with dynamic, decision tree regulatory assessments

Enforce deliverable requirements as per the approved Master Validation Plan (MVP) and validation procedures, which are typically buried in documents

ValGenesis Validation Lifecycle Management System Modules

Validation Plan and Framework 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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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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