• 100% browser-based system with zero footprint clients
  • Single instance to manage multiple sites through Multi tenant design
  • Integrates with your LDAP or Active Directory
  • Single Sign-On (SSO) support
  • Offline (similar to “flight mode”) data entry in Mobile App
  • Automated emails, alert notifications, and escalations
  • Out-of-office delegation and task reassignment
  • Design your own review/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

Business Process Modeling

The ValGenesis VLMS can be easily configured to define any process model to meet the complex requirements of validation, change control, and risk management. Our flexible configuration model provides several benefits:

  • Decision tree driven system assessment
  • Define a validation framework and enforce required deliverables based on risk level and/or Master Validation Plan
  • Model validation process flows for specific validations
  • A web-based user interface allows design of simple and/or complex validation process models
  • Build reusable approval cycles that support simple and/or complex workflows, with support for queues and workload balancing
  • Multi-level approvals and task delivery notifications on multiple channels
  • Out-of-box connectors and adapters for Enterprise Resource Planning (ERP) systems with a certified connector for SAP
  • Validated connectors for Document Management systems and Microsoft SharePoint
  • Connectors for Automated Test Engines, with validated connectors for Microsoft VSTS (Coded UI) and TOSCA
  • Define organization-specific KPIs for measurable performance
  • Delineated exceptions and task alerts delivered to a designated inbox

Multisite Functionality

Our VLMS supports multisite functionality, making it possible to group all processes at the business unit or site level. VLMS provides users with several significant advantages:

  • Single validation management system for global organizations to support all types of validation processes.
  • Minimal infrastructure requirements
  • Additional application servers (virtualized) can be deployed for load balancing
  • Single backup and disaster recovery procedures
  • No need to perform extensive validation when adding new sites
  • Ability to enforce global standards for templates and procedures
  • Leverage validation data and content from other sites to reduce cycle time when creating requirements and protocols
  • Users from different geographical locations can easily collaborate on validation projects
  • Instant visibility of validation and project statuses across the entire organization

Multilingual Support

Our VLMS offers multilingual support for several commonly encountered languages, including German, French, Chinese, Japanese, Portuguese and Spanish (with English as the default language setting). Our applications can provide clients with a global system that offers the option for other languages to be selected at the site level. Multilingual support such as this is a crucial component for any global organization.

Mobile App with offline Mode

The ValGenesis VLMS’s mobile app provides users with the ability to download documents from the server and enables validation engineers, reviewers and approvers to perform critical activities even if they are not connected to the ValGenesis server. This offline functionality provides users with several distinct advantages:

  • Ability to electronically execute documents even when not connected to the network or internet
  • Users can download a document, disconnect from the network, runit electronically while disconnected, and then synchronize back with the server once a connection is re-established
  • Our users have the power to author content without a network or wireless connection
  • Authored and/or executed content can be reviewed, once downloaded, without the need for a live link to the ValGenesis server

SAP Integration

ValGenesis is a certified SAP partner and has developed integration scenarios to work with SAP systems for seamless bidirectional data transfer. These integration scenarios allow ValGenesis VLMS to complement your organization’s existing SAP solution and provide additional integration tools to supplement our robust and proven integration options.

In most scenarios, assets (instrument, equipment etc.) are managed within SAP. With our integration, equipment details are dynamically populated in ValGenesis through a validated interface. The validation process is managed within ValGenesis VLMS, and once an asset (instrument, equipment, computer system etc.) is validated, the status of the asset is updated in SAP. Once all validation tasks have been completed and reviewed, the validation status updates and performance indicators are passed to SAP for aggregate analysis to allow for better business decisions.

Document Management System Integration

ValGenesis provides validated connectors for commonly used document management systems (DMS). This interface allows for an end-to-end, secure, 100% paperless validation life cycle management solution equipped with central storage of all validation documents and other data provided by the two complementary systems.

This interface enables seamless global access, retrieval, and storage of corporate validation data and documents generated by ValGenesis VLMS within the corporate DMS. Users can leverage real-time reporting and the level of search capability found in most DMS platforms. Furthermore, document management staff can apply federated retention policies to unify management practices across all documents and record types throughout the organization, ensuring continuous compliance with all regulatory requirements.

Integration with Test Automation Tools

Automated testing tools such as the Tricentis TOSCA or Microsoft Visual Studio Team System (VSTS) are designed to allow users to program sophisticated tests that can bring out hidden information from software applications. With automated testing tools, more tests can be run in significantly less time and with fewer resources. Leveraging automated testing tools for validation requirements will dramatically reduce validation cycle time and cost.

On their own, of course, test automation tools do not meet the regulatory compliance requirements regarding controlled workflows and content management, audit trails, accountability, and e-signatures. The integration of ValGenesis VLMS with automation testing tools leverages the power of automated test engines in combination with the compliance controls needed to meet stringent regulations. The integrated system provides automated software validation that is fully compliant.

Critical phases of the validation process—planning, requirements management, traceability, risk assessment, periodic review, and change control—are harmonized by an automated validation process. Approved validation documents, generated via an automatic validation process, are stored in the Library module of our VLMS, but they can also be migrated into any corporate DMS.