FDA regulated companies must establish quality systems for compliance. Most quality management systems (QMS) were developed to help comply with regulations with a sole focus on automating the paper-based processes around quality.
However, product companies soon realize that document-centric QMS systems fail to capture the comprehensive product record. Medical devices that are comprised of mechanical, electrical, software, assembly and test procedures, and other documentation necessary to design, produce, and improve innovative products require a more comprehensive solution.
Arena’s Bill of Material (BOM) based approach enables medical device companies of all sizes to optimize quality management in the context of managing the entire product record. Arena BOMs link to CAPA, engineering changes, and other product-driven processes. In this way, Arena maintains easily audited electronic Device Master Records (DMRs) and Design History Files (DHFs).