Enabling Design Controls

Every part of the design process must be supported by a document in the DHF, and every document and component in the DMR must be well controlled. Design controls requirements stipulated in 21 CFR 820.30 include:

• Design and development planning
• Design input, including intended use and user needs
• Design output, including evaluation of conformance to design input requirements
• Design review
• Design transfer ensuring that the device design is correctly translated into production specifications
• Design changes
• Design history file (DHF), a demonstration that the design was developed according to the approved design plan

FDA Design and Development Overview Process Flow

Issues with design controls are magnified when the right tools for managing design and quality are not in place or not connected. Paper-based systems are one such example, causing countless errors, bottlenecks, and inconsistent information. And while document-centric QMS tools go a step further by automating some aspects of document management, their limited functionality leaves quality, design, and other key components of the product record disconnected and inaccessible.

In contrast, Arena’s product-centric QMS approach ensures the entire product record (e.g., parts, BOMs, AML, drawings, packaging, specifications) and quality record (e.g., CAPAs, DHFs, DMRs, NCMRs) are connected throughout the entire product lifecycle. This connected QMS methodology enables full traceability for all key stakeholders from engineering to quality to operations and the entire supply chain. This creates stronger design controls and gives everyone more confidence to face and address FDA or other audits.