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.