Download Aras Innovator
We're a progressive company, and we want to work with other forward-thinking companies who can help us eliminate organizational silos and increase collaborative development to achieve a competitive advantage in the marketplace.
Bruce Leidal, CIO
Carestream Health

Aras Standards | FDA Software




Aras FDA
The U.S. Food and Drug Administration (FDA) requirements are designed to protect the public health by assuring the safety, effectiveness and security of food, drugs, biologics and medical devices. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications, known as Current Good Manufacturing Processes (CGMP) and the Quality Systems Regulation (QSR).

Aras & FDA :

  • Automates and manages all the information and processes required to manufacture parts, assemble final products and conduct product quality inspections
  • Supports 21 CFR Part 11 for Electronic Documentation and Records Management, with Workflow, Configuration and Change Management, Version Control and Revision Management, Notification and e-Signature, Multi-Level BOM, Affected Items, Audit and Part Traceability in a Secure, Closed-Loop Environment
  • Supports 21 QSR Part 820 for Quality Planning and Processes, with Manufacturing Process Planning, Quality Systems, Requirements Management, Compliance, Reporting & Analytics, Supply Chain Management and Supplier Preventive and Corrective Action (CAPA)