Functionality that fosters GDPR Compliance
In the March 22 we wrote about Are You GDPR Ready? and highlighted ValGenesis functionality to help organizations comply with GDPR, which included:
- Complete Lifecycle management
- Decision Trees to determine consistent, compliant outcomes
- Inventory of systems, including their validated state
- Real-time impact notification of changes
- Risk Management
- Scheduler for Periodic Reviews and Re-Validation
Now that GDPR is in effect, since 25 May 2018, we thought you’d like to better understand available functionality that ValGenesis customers can leverage.
Complete Lifecycle Management
It’s important to manage a system throughout its lifecycle, from inception to retirement. The ValGenesis VLMS does just that. From initial assessments and planning at the beginning, through requirements development and management, formalized testing, release to production, and controlled changes through to retirement. A real-time inventory that reports on status is maintained throughout the lifecycle.
This functionality is important because it drives consistency and compliance with the ability to act on resulting outcomes. Decision Trees are configurable allowing customers to tailor their own questions to meet their unique requirements. This functionality can be embedded into initial assessments as well as Frameworks that establish deliverable requirements.
Requirements, Test Functions, Traceability and Impact
GDPR specific requirements can be established to ensure all systems deliver necessary functionality. Test Functions are unique to ValGenesis. Essentially, this is a library of callable tests that can demonstrate functionality is delivered, and is working as intended. The system links requirements to tests and, as a result, can immediately report impact when and if things change.
GDPR allows and encourages a risk-based approach. This is delivered in ValGenesis at both the System and Functional level. Risk Processes can be tailored to meet customer-specific requirements. Standard risk models are also delivered allowing the ability to jump-start automated risk management practices and processes.
Finally, the ValGenesis VLMS includes a Scheduler module that supports Periodic Reviews and Revalidations. A periodic review can be based on a standard worksheet, totally configurable by the customer. Activities can be planned, initiated, and tracked through to completion. If deadlines are near or even missed, the system will report that out accordingly to pre-determined groups. Any-or-all systems can be assessed in a consistent and methodical manner to demonstrate compliance is achieved, such as GDPR, and all objective evidence will be maintained in a controlled manner that is readily available for review.
To learn more please don’t hesitate to contact us. For more information visit www.valgenesis.com
About the Author
Steve Thompson is Senior Manager of Professional Services and is responsible for managing ValGenesis’s Implementation & Professional Services in the West Coast Region of the United States. Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California. GDPR GDPR Compliance Life Science Industries