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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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Equipment Log Management

With ValGenesis, users have the power to electronically capture and route equipment cleaning, preparation and usage logs with verification through managed workflows. Authorized users can design equipment logs, forms, and labels according to approved protocol and procedures. Equipment logbooks are a regulatory requirement FDA 21 CFR 211.182.

Products Equipment Log Management
Equipment Log Management

Paper-based equipment logbooks are inefficient and prone to compliance issues. Manually recording logbook entries requires that at least two people be physically present. A required signature, by two people, for every logbook entry reduces productivity and introduces the potential of human error.

Furthermore, reviewing historical logs requires manually sifting through binders and stacks of paper. In addition, finding these logs typically requires navigating through a labyrinth of filing cabinets. In short, paper-based equipment log management will not sustain a continuous monitoring process.

 

Advantages of ValGenesis VLMS:

Visibility of all logs, forms, and labels to authorized users 24/7/365, anywhere in the world

Logbooks secured electronically preventing loss or misplacement

Unlimited log, form, and label creation

Mobile devices including Android and iOS are supported

Real-time status and Log inventory that is comprehensive and accurate

Technical controls that enforce quality requirements and automatic notification through email

Disaster recovery and business continuity is assured by the fault tolerant, redundant, and fail-over infrastructure

Nudge feature to ensure tasks are not missed, or escalated if necessary; Logs are consistent, enduring, and readily available

Reporting and trending through ad-hoc reports

Supports continuous monitoring of production processes

ValGenesis Validation Lifecycle Management System Modules

Equipment Log 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

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