Product-Centric QMS: A Critical Advantage for Regulated Companies

Arena’s Product-Centric QMS Approach

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.

A Different Way: Managing Records With Live Links

Arena takes into account that documents, change orders, BOMs, suppliers, CAPAs, DHFs, DMRs, and other product information are interrelated.

Engineering change orders (e.g., ECRs, ECOs, deviations, stop ships) are more than static documents or simple forms in Arena. They drive complex workflow approval processes and post-release actions. For example, when all of your stakeholders have approved any given change order, its release automatically incorporates all BOM redlines into the latest revision. This release can then trigger the transfer of the new items, BOMs, suppliers, and manufacturers’ information into your ERP system for planning and production purposes.

The release can also include an SOP change that may require a training plan review.

Arena maintains the necessary relationships between the change order and its affected parts, assemblies, quality records, and documents. To drive procurement and manufacturing accurately, the ECO’s disposition codes— coupled with effectivity dates—allow for optimized planning and production. And the relational BOM includes component quantities and units of measure to drive your enterprise resource planning (ERP) later in the new product introduction process.

AML, AVL, and associated part information also require unique functionality. Arena’s AML/AVL capabilities provide management of manufacturers’ part numbers, internal part numbers, and the supplier’s (or distributor’s) part numbers so that your procurement teams can effectively plan and procure parts. With Arena, our AML functionality helps you identify and eliminate the use of duplicate manufacturers’ parts, reducing costs through higher volume purchasing.

Managing Records With Live Links