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.