ESTABLISHED VALIDATION & COMPLIANCE MANAGEMENT PLATFORM
Expanded and optimized over more than a decade, our platform can address every critical technology element of a life science enterprise.
PLATFORMS / Technology
ValGenesis’s established validation and compliance management platform has been continuously expanded and optimized by our development team over the span of more than a decade. As a result, it is capable of addressing the critical technology elements required to serve any life science enterprise:
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
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
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
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
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.