FDA Compliance for Manufacturers

​​​​​​​​​If you are a manufacturer in a highly regulated industry, maintaining FDA compliance for software validation is a daunting task — especially for transaction-oriented systems like ERP. That's why we offer the comprehensive Fullscope FDA Validation Toolkit to facilitate the development of mandatory software validation deliverables in an easy-to-use package.

The toolkit includes unprecedented services, coupled with validation starter templates, protocols and scripts, to let you quickly and cost-effectively navigate the complicated FDA software validation process. The latest version 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                             

Who Needs It

Manufacturers who must meet and maintain FDA regulatory 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. 

How FDA Compliance Works

The U.S. FDA and other similar regulatory agencies worldwide validate your implementation and use of software rather than the software itself, forcing you to conduct a complete FDA software validation process.  The software, documentation and services provided in our FDA Validation Toolkit can help reduce the time and effort required by capturing as much of the standard information.

Software & Services

Additional software in the FDA Validation Toolkit provides 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.

 Fullscope FDA Validation Toolkit for Microsoft Dynamics AX 2012

     Templates included:

  • Validation Master Plan (with risk assessment)
  • Requirements Disaster Recovery
  • Software Traceability
  • Validation Test Plan
  • Supplier Audit Check List
  • Internal Procedures
  • Signature Matrix
  • Validation Standard Operating Procedures
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary Report

Learn about our other solutions for manufacturers:

Download FDA Validation Toolkit Fact Sheet
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