Product-Centric QMS A Critical Advantage for Regulated Companies


Companies regulated by the FDA must establish quality compliance systems. Most quality management systems (QMS) have been developed to help comply with the regulations, with the sole focus on automating the paper processes.

Arena’s product-oriented approach allows medical device companies of all sizes to optimize quality management in the context of managing the entire product record. The entire Arena product record is linked to CAPA, technical changes and other product-driven processes.