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.

In November 2011, Fullscope released the new FDA Validation Toolkit for Microsoft Dynamics AX 2012. New functionality includes:

• A readily deployable Validation document management portal with a Validation Dashboard
• Role based security OQ script
• Incident management form and Supplier audit checklist
• Disaster recovery plan
• Hardware specifications document

The FDA Validation Toolkit works with Microsoft Dynamics AX 2012.

Who Needs It

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.

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 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.

Software & Services

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 on-site assistance from experienced validation consultants to implement the software, plan the validation project and complete the templates.