Providing a Superior Foundation for Your Corporate Quality System
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.