Paperless validation software has revolutionized traditional validation practices. Reliance upon hardcopy documentation is eliminated, making the overall validation lifecycle significantly more efficient, with effort and cost savings at approximately 50%. A Software as a Service (SaaS) validation solution is also far more reliable, with 99.999% availability of a cloud-based software solution.

With paperless validation software, workflows are automated, compliance requirements are instantiated in automated processes, and electronic signatures are performed via instantaneous routing along with automatic notifications. Metrics, dashboards, and reporting are immediately available. Requests during audits and inspections are fulfilled with minimal effort. Standards are implemented and consistency is therefore attained as it pertains to requirements management, testing methodology, and risk management. Disaster recovery and business continuity is achieved via the cloud, delivering High Availability (HA), fault tolerance, failover, security, and data privacy, which are all held to the highest standards possible.

The need to salvage through volumes of hardcopy documentation and chase down individuals to obtain approval signatures vanishes with paperless validation software. The right record is always readily available at the right time.

Organizations can realize more benefits and features by implementing the right paperless validation software solution.

Product Features

ValGenesis’s Validation Lifecycle Management System (VLMS) is chock-full of features and functions that are designed to significantly improve traditional validation processes. Our system provides a holistic view of the entire validation process, comprehensive validation lifecycle management functionality, and the ability to integrate with existing systems.

Holistic View of Validation Process

With a holistic view of validation processes, users can view Validation Metrics, Real-Time Validation Status, and a Validation Calendar. Also, this holistic view layer delivers innovative solutions not limited to Workflow Designer, Automatic Execution, and Dynamic Traceability.

Validation Lifecycle Management

The Validation Lifecycle Management layer of the system includes Functional Modules along with Supporting Modules.

Functional Modules

  • Validation Planner
  • Risk Manager
  • Requirements Manager
  • Content Manager
  • Log Manager
  • Validation Scheduler
  • Electronic Executor
  • Deviation Processor
  • Change Manager

Supporting Modules

  • Configuration Manager
  • Administrator
  • System Manager
  • Ad Hoc Reporter
  • Library
Integrations

The ability to integrate with a customer’s existing systems is achieved through ValGenesis’s Web Services and extensive Software Development Kit (SDK). Integrations include, but not limited to, the following:

  • CMS: Calibration Management Systems
  • DMS: Document Management Systems
  • ERP: Enterprise Resource Planning
  • LIMS: Laboratory Information Management Systems
  • LMS: Learning Management Systems
  • MES: Manufacturing Execution Systems
  • QMS: Quality Management Systems
  • TAE: Test Automation Engines

Process

The ValGenesis’ (VLMS) is comprehensive, spanning the entire validation lifecycle. The following illustrates the ValGenesis VLMS in operation, and what it takes to configure and deploy the system.

ValGenesis VLMS in Operation

For maximum benefit, customers can develop standard, reusable requirements and tests (optional). Pre-approved requirements (with associated risk assessments) and tests are selected to automatically populate corresponding electronic documents, which can then be augmented to meet specific needs of a validation activity.

Documents are routed (via serial, parallel, or hybrid paths) through custom workflows for review / approval. Once approved, validation activities are electronically assigned to individuals or groups. Activities are then accepted and executed. Automatic notifications occur via email and are also accessible via the system’s Graphical User Interface (GUI).

Any deviations are automatically processed and routed for review /approval. Trace Matrix is automatically generated throughout the process.

Once completed, electronic validation deliverables are reviewed and approved. Metrics, dashboard, and reporting functionalities allows authorized individuals  to check all aspects of progress via the GUI.

Anything that can be validated is managed as an entity. This includes all validation artifacts associated with an entity (e.g., document deliverables). Changes to an entity or artifact can automatically trigger validation or re-validation activities as pre-determined by customers.

Configuring and Deploying the ValGenesis VLMS

Configuring and deploying the ValGenesis VLMS, including validating the system itself, is rapid because it is delivered as a cloud-based, SaaS solution.

The core system is already validated in the cloud. Customers leverage the core validation, augmenting it to meet the requirements of their own Quality Management System (QMS).

A multi-disciplinary team of highly qualified industry professionals at ValGenesis assist our customers with the configuration and implementation of the system. On-site workshops are conducted to ensure the system is configured and deployed to meet the unique requirements of each customer, therebyfore ensuring the system performs as intended. Extensive training is conducted for System Administrators and for the different User Roles (e.g., Developers, Executors, Approvers, Quality, etc.).

Electronic Deliverables / Electronic Records

Electronic document deliverables are instantly routed through predefined workflows. Immediate notifications occur via email and all tasks, along with their respective statuses, are accessible through the system’s interface. Dynamic graphs present statuses and allow authorized users the ability to drill down to observe ever- increasing detail.

Electronic Execution

Electronic execution makes actual validation more efficient, effective, consistent, and compliant. Because the ValGenesis VLMS is a cloud-based SaaS solution, it’s always available to authorized users. Tasks can be split and delegated to different individuals or groups, globally. Deviations are immediately captured and processed electronically through predefined workflows for review and approval. Change Management is integrated so change impact of change is immediately assessed at the risk assessment and/or requirement level.

Regulatory Compliance, Consistency, and Re-Usability

Compliance is attained through consistency and an available Regulatory Framework that can be leveraged to prescribe validation packages based upon any number of regulatory requirements. Libraries of recurring tests can be created via pre-approved Test Functions that not only deliver consistency, but also make protocol generation significantly more efficient. Requirements can also be reused, saving time while ensuring consistency. Risk can be assessed, assigned to requirements, and linked all the way through to the level of Test Steps. Because the system knows the requirements, associated Risks and Tests, a change can automatically trigger revalidation activities based upon risk or Regulatory Framework, thus allowing an immediate assessment of change impact.

The end result is a regulatory compliant, consistent VLMS solution that maximizes re-usability, is extremely efficient, and always available, anywhere and at any time.