Product-Centric QMS: A Critical Advantage for Regulated Companies Confirmation
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.
However, complex product companies 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 product-centric approach enables medical device companies of all sizes to optimize quality management in the context of managing the entire product record. Arena’s entire product record is linked to CAPA, engineering changes, and other product-driven processes.
In this white paper, find out how Arena:
Provides corporate wide visibility of full product records & associated processes
Enables enterprise & supply chain collaboration
Offers a closed loop corrective action preventive action (CAPA) process
Simplifies enterprise software system validation