Dynamics AX

    Process Industries for      Microsoft Dynamics AX

    High Tech & Electronic      Industries for Microsoft      Dynamics AX

    Total Quality Management      for Microsoft Dynamics AX

    FDA Validation Toolkit

FDA software validation within highly regulated life sciences systems environments can be a daunting task — especially for transaction-oriented systems such as enterprise resource planning (ERP).  Fullscope understands the unique challenges facing life sciences companies and offers the comprehensive FDA Validation Toolkit to facilitate the development of mandatory software validation deliverables in an easy-to-use package.

The U.S. Food and Drug Administration FDA Validation Toolkit offers unprecedented services, coupled with validation starter templates, protocols and scripts, to let pharmaceutical manufacturers or other life sciences companies quickly and cost-effectively navigate the complicated FDA software validation process.

The FDA Validation Toolkit complements Process Industries for Microsoft Dynamics AX, process ERP software developed by Fullscope as part of the Microsoft Dynamics Industry Solution program.

Manufacturers who must meet and maintain FDA compliance, including producers of medicinal and botanicals; pharmaceuticals; diagnostic substance; biological products; surgical and medical instruments; orthopedic, prosthetics and surgical appliances; dental equipment and supplies; and ophthalmic supplies can benefit from the FDA Validation Toolkit.  These companies must demonstrate that they can meet the processing, safety and tracking standards required by law.

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 FDA software 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.

Additional software in the FDA Validation Toolkit provides users with options to manage the validation process, track company-specific changes made to Microsoft Dynamics AX, and monitor on-going compliance status.  The consulting services feature an on-site assistance from experienced validation consultants to implement the software, plan the validation project and complete the templates.