Technology Overview

ValGenesis VLMS is a web-based, modularized, configurable and integrated enterprise validation lifecycle management solution. ValGenesis VLMS is a multi-site application whereby a single instance of the system can be used for any validation process across multiple sites within your organization. Each site that is created in ValGenesis VLMS can be configured differently with different sets of data. Users can be given different levels of access to the functions and data within each site.

ValGenesis VLMS can be implemented quickly within your organization’s network or on the cloud and can be accessed from anywhere. ValGenesis allows Life Sciences companies to reduce the validation cycle time, eliminate non-value added activities, standardize the validation process across the company, enhance compliance and reduce the risk of non-compliance.

ValGenesis’ established validation and compliance management engineering platform has evolved for over a decade and addresses the critical technology elements required to serve global life sciences enterprises.

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  • 100% browser based system with zero footprint clients
  • Single Instance to manage multiple sites through Multitenant design
  • Multi lingual support at the Global or Site level or User level
  • Compliant with 21 CFR Part 11 and Annex11
  • Integrates with your LDAP or Active Directory
  • Single Sign-on support
  • User and role level security
  • Offline data entry capability
  • Automated email & alert notification & escalations
  • Out of office delegation and task reassignment
  • Design your own review and approval workflow with serial, parallel, and combination routing
  • Web Service and API integration
  • PDF generation with watermarking
  • Ad-hoc Report Writer
  • ISO 9000:2008 Certified Development process

Platform and System of Record for Corporate Validation Process

  • Designed for regulated Life Sciences company requirements
  • Designed for Validation, Application Lifecycle, Change and Risk management requirements

Validated, pre-configured with best practices

  • Meets validation needs of multi-site global enterprises
  • Provides closed loop interface with existing manufacturing and line-of-business applications

Single Instance for all types of validation and quality Processes

  • Single Instance of ValGenesis can be leveraged to manage all validation processes including:
    • Computer Systems validation
    • Instrument and Equipment validation
    • Cleaning Validation
    • Method validation
    • Process validation
    • Preparation, Cleaning, and Usage Log Management
    • Application validation management

Deployment Options

  • Available to deploy on premise within your network or in the cloud
  • Same system functions, regardless of deployment option

ValGenesis Cloud

  • Enterprise-class operations from an SSAE 16-certified hosting facility
  • Validated cloud with IQ, OQ and PQ
  • Continuous monitoring
  • Load balancing and advanced security features
  • SSAE 16 SOC 2 Type I certified hosting
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