What is Validation Management Tool?
Validation Management Tool (VMT) is a comprehensive and collaborative validation management solution for complex healthcare systems. It can help you improve the quality of Medical devices (Class I II III), Electronic Medical Records (EMR/EHR), clinical informatics, pharmaceutical informatics and more.

As the products and validation requirements become more complex, it becomes very difficult for the executive management to determine the depth and breadth of product validation. VMT has an interactive graphical dashboard providing real-time test status information. As a result, you get better visibility and insight into the management of the system development life cycle process in your organization.

With a single, centralized repository and support for the entire product lifecycle including requirements, test procedures, test cycles, bugs, risks and issues, VMT provides complete traceability and improves coverage. VMT provides role-base collaboration that automates the information flow during the development process, facilitating reporting and reducing manual overhead.

VMT is fully compliant with regulatory FDA and CE standards including 21 CFR part 11 and simplifies the submission process with automated report generation.

Benefits

See a clear picture of status with the Analytics Dashboard
Achieve full traceability based on a single end-to-end information repository
Comply with Regulatory standards and automate generation of submission reports
Manage all your scripted and Exploratory testing in one place
Promote role-based collaboration across your organization

Features

Analytics Dashboard
VMT offers an intuitive and interactive Analytics Dashboard that presents a high level picture of the validation coverage, extent of test execution, matrices of current defects and includes graphical defect trending reports by product, components or project. With the Analytics Dashboard, you can drill down into the details and personalize the views to receive relevant, real-time information.

Complete Product Lifecycle Validation
VMT offers an intuitive and interactive Analytics Dashboard that presents a high level picture of the validation coverage, extent of test execution, matrices of current defects and includes graphical defect trending reports by product, components or project. With the Analytics Dashboard, you can drill down into the details and personalize the views to receive relevant, real-time information.

Traceability
VMT facilitates traceability and verifies coverage of all specified functionality, standard compliance and ant other type of requirement. With VMT, you can generate traceability reports at a click of a button.

Regulatory Report Generation
VMT support FDA and CE certification compliant reports. It can help you in the documentation processes including reporting for 510K or PMA submissions.

21 CFR part 11 compliance
VMT meets the FDA 21 CFR part 11 requirements for electronic records including audit trail and the implementation of digital signatures. A standard or customized version of VMT can be quickly and formally validated as part of a VMT implementation.

Exploratory Testing Support
VMT supports Exploratory Testing as well as standard scripted testing. It has a dedicated module that helps you manage Exploratory Testing sessions. With VMT, you can plan Test Charters and the Test, raise issues, facilitate the note taking process and create test Logs.

Role-Based Collaboration
VMT enables each group or department to input their information directly using their existing processes with no data overhead. Product Managers can define product components, product versions, product feature specifications and high level requirements; R&D can specify product builds and detail requirements; Quality Assurance and Validation Managers can plan and design test protocols and test cycles as well as assign test executions to testers who log test results and defects.

Scalable & Secure
VMT is based on Intuit’s Quickbase SAS architecture. It can support thousands of users across multiple business units and geographical regions. The role-based access ensures data security while an online, web-based interface deliver ease of administration and usage.

Out-of-the-Box or Customize
VMT includes recommended workflows, forms and report out-of-the-box. Alternatively, QualiTest can quickly customize fields, screens, workflows, reports and user permissions to meet your exact needs.