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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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Risk-Based Validation

Validation risk assessment is a structured and documented approach for assessing risks in a computerized system, as well as for equipment, instruments, and processes.

Products Risk-Based Validation
Risk-based Validation

Applying risk assessment procedures to validation is a highly effective means of ensuring that all critical requirements are tested – with the appropriate level of documentation – to validate/verify a system or process.

Validation risk assessment is a structured and documented approach for assessing risks in a computerized system, as well as for equipment, instruments, and processes.

Our VLMS comes equipped with convenient Risk Assessment tools that provide clients with several significant benefits:

Supports most commonly adopted risk management processes including FMEA

Supports decision tree driven risk assessment

Users can mirror current risk assessment procedures without customization of the system

Users can conduct risk assessment for the computer systems, equipment, instruments and processes

Supports with built-in best practices for risk management, clients can leverage these prebuilt risk models, templates and decision trees who want to improve the current risk management process

Based on the risk profile, the required level of validation or verification effort needed for the system to be considered validated or verified can be determined

Users can conduct risk assessment at the functional or system level

Functional risk assessment allows users to determine the amount of testing required (based on risk level)

ValGenesis Validation Lifecycle Management System Modules

Risk-Based Validation 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

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.

Schedule a Demo