Arena QMS is a compliant product-centric solution to control and manage your NPD processes from product concept through sustaining, improvement, and end-of-life. To do this, Arena QMS aggregates your product information into a hierarchical BOM that specifies all of the components, subassemblies, and associated documents required to design, test, build, and ship your product. Managing the complete product record along with the quality system requirements in a single solution helps you ship quality products on time. Product-centric QMS accelerates your NPD process and facilitates tighter control of your product design as you strive to reduce cost, improve compliance, and drive continual improvement.
Arena QMS connects quality records and closed-loop processes to a comprehensive product development platform. The QMS software solution helps manage design controls, device master records (DMRs), and design history files (DHFs), while providing increased visibility and traceability. Arena QMS also provides software validation services and automated review and approval processes with electronic signatures that simplify compliance to FDA 21 CFR Part 11.
“A big advantage managing quality in Arena is the ability to link quality records to the part record and bill of materials. Since our initial implementation, we’ve improved complaint investigation duration and timeliness of CAPA management through process improvements supported by Arena’s product-centric quality management system approach.”
– Chris Hill, Director of Quality, Organ Recovery Systems
For superior document management, Arena’s cloud-based QMS controls versions and revisions of drawings, specifications, standard operating procedures (SOPs), assembly and test instructions, software code, and any type of files in context of the entire product record. The difference with Arena’s connected QMS approach is that every document, part, manufacturer, and vendor is linked directly to its related specific component or item on the BOM. This ensures everyone can see every document and how it relates to the product design.
Design History File Management
With Arena QMS, you can effectively capture design decisions, meeting notes, design quality documentation, and quality records while providing a process to guarantee that all information is tracked, controlled, and documented as you move through the design and development process. Our comprehensive approach to DHF management provides not only the control you require but also the invaluable transparent links to any part of the DMR you need to increase product success.
