Arena also electronically tracks and maintains requirements, test details, and electronic approvals linked to the appropriate part of the product record. Arena tracks design control elements and deliverables for the impacted product, quality, and production teams.
This simplifies regulatory compliance and ensures responsible team members are always aware of key action items and project deliverables. Maintaining regulatory information in context with the product record makes it easy to respond to and pass audits, ultimately speeding product launches. Furthermore, for medical device manufacturers, Arena manages device master records (DMRs), design history files (DHFs), and validation maintenance services to simplify FDA compliance and software validation. This ensures quality processes meet intended uses per FDA Title 21 CFR Part 820 (i).