PLM for Life Sciences

To meet FDA and other regulations, life science and medical device companies must be able to manage information to show evidence of compliance while accelerating time to market. Arena makes audits easier and less time consuming with a cloud-based solution that consolidates all compliance information into one centralized system. The solution streamlines management of BOMs, the design history file (DHF), the device master record (DMR), and change orders. Arena focuses on assisting medical device companies in meeting 21 CFR Part 11 Federal Regulations and enables Part 11 compliance by offering an application containing the required technical elements of a compliant system.