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Fullscope's FDA Validation Workbench is designed to assist life sciences companies to achieve and maintain U.S. Food and Drug Administration (FDA) validation. The new option complements Process Industries for Microsoft Dynamics AX, supply chain management software also developed by Fullscope as part of the Microsoft Business Solutions Industry Builder ISV (IBI) program.

Who Needs It
Companies that manufacture medical devices, pharmaceuticals or other regulated substances must demonstrate that they can meet the processing, safety and tracking standards required by law. Fullscope's FDA Validation Workbench includes software for tracking and managing validation activities, templates for completing the documentation required by the U.S. FDA, documentation for a vendor audit of Process Industries for Microsoft Dynamics AX, and consulting services to assist the manufacturer in completing the validation process.

How It Works
The U.S. FDA and other similar regulatory agencies worldwide validate a manufacturer's implementation and use of a vendor's software rather than the software itself, forcing each life sciences company to conduct a complete validation process. The software, documentation and services provided in the FDA Validation Workbench can help reduce the time and effort required by capturing as much of the standard information as possible from each manufacturer.

Software & Services
Additional software in the FDA toolkit provides users with tools to manage the validation process, track company-specific changes made to Microsoft Dynamics AX, and monitor on-going compliance status. The consulting services feature 25 days of on-site assistance from experienced validation consultants to implement the software, plan the validation project and complete the templates.

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