GoVal – Revolutionizing Computer System Validation with Scripted and Unscripted Testing Approaches
Computer system validation is a critical process in regulated industries such as pharmaceuticals, biotech, medical devices, and healthcare. The process involves several stages, including User Requirement Specification (URS), risk assessment, GXP assessment, testing, and reporting. Recently, the FDA introduced new guidelines that allow companies to adopt an unscripted testing approach for their computer systems’ validation. In this article, we will explore the process flow followed in GoVal for both scripted and unscripted testing approaches.
How does GoVal approach scripted testing?
GoVal offers a scripted testing approach where test cases are created based on predetermined scenarios. These tests are routed for pre-approval before execution. Evidence is uploaded, and any defects or discrepancies are tracked and managed through the system.
How does GoVal approach unscripted testing?
GoVal follows the new FDA guideline for unscripted testing, which involves assessing the risks associated with each requirement and assigning a risk rating. The system generates a summary of the validation with deviations and reports, which are reviewed and approved by all stakeholders.
What is the benefit of using GoVal for unscripted testing ?
Using GoVal for unscripted testing allows for a more efficient and targeted approach to testing. By assessing the risks associated with each requirement, testing efforts can be focused on the most critical areas. The summary of validation with deviations and reports also provides a clear and concise overview of the validation process
How does GoVal help with digital transformation?
GoVal is a cloud-based solution that enables remote access and collaboration, making it easier for organizations to manage their CSV process from anywhere. Its user-friendly interface also simplifies the process and reduces the need for extensive training.
In summary, GoVal is a comprehensive solution for managing the CSV process, offering both scripted and unscripted testing approaches. Its user-friendly interface, cloud-based solution, and adherence to FDA guidelines make it an ideal tool for organizations undergoing digital transformation
What is the benefit of using GoVal for scripted testing?
Using GoVal for scripted testing ensures that all necessary scenarios are covered and all evidence is captured in one place. The routing and pre-approval process also ensures that all stakeholders are involved in the testing process, improving communication and collaboration.
What is GoVal and how does it simplify the computer system validation (CSV) process?
GoVal is a user-friendly tool that helps organizations streamline their CSV process. It provides an end-to-end solution for managing the CSV lifecycle, from URS (User Requirement Specification) to validation summary reports. GoVal also offers CSA (Computer System Assurance) and cloud solutions for easy access and collaboration.