What is Arena Quality?
Arena Quality is a cloud-based quality solution designed to bring interdisciplinary visibility, supplier collaboration, and long-term tracking of quality resolutions to the enterprise's core. Specifically, it enables companies to create and better meet ISO standards, FDA regulations, and a spectrum of other product quality business processes, including; 21 CFR Part 11, 21 CFR Part 820, NCMR, CAPA, and 8D. And it's all embedded into Arena PLM for holistic visibility.
Arena Quality is built for companies ranging from large high tech multinational enterprises that need to unify global business units to small medical device startups in need of an efficient, compliant quality system. Regardless of a company's size or industry, Arena Quality enables continual process improvements, higher quality products, and cost reductions across the entire value chain.
With Arena Quality, connections to items, changes, requests, files, projects and other quality processes, including outside links, result in a more comprehensive solution than with other quality modules. Alternatives connect only to parts and assemblies and have to be cross-checked against a PLM solution that does not interface with an independent Quality module.
Arena Quality offers highly regulated companies, such as medical device manufacturers, and high technology OEMs a watertight solution. By integrating quality processes directly with the product record, Arena ensures quality records are captured and maintained to demonstrate adherence to regulatory requirements. Suppliers can be held accountable as all quality issues are aggregated in a centralized location. With Arena Quality, companies capture a more complete quality picture, allowing auditors to quickly and easily verify compliance in context All the people, see all the stuff, all the time.
While other solution's economics restrict collaboration and ownership to a handful of licenses, Arena Quality enables every individual in the company as well as their supply chain partners, to engage with an open privilege model. This allows all users to initiate and drive the process. The entire team is empowered to promote continuous improvement in the product.
This module is completely integrated with Arena PLM records and processes to ensure engineers, manufacturing, quality and supply chain teams have in-context visibility to all quality issues as they design, review, improve, and build your products. In addition, suppliers can be included as assignees and owners, as well as fully involved in any quality process shared with them, such as interactive CARs and SCARs.
- Provides a closed-loop corrective action, preventive action (CAPA) process. Helps identify internal and external issues, drive root-cause analysis and determine resolution.
- Suppliers' participation is encouraged, as assignees, owners and creators, in every aspect of the process. It allows quality managers to strengthen their supply chain bond to better share and solve issues faster, resulting in higher product integrity as well as facilitating audits.
- Add one or more sign-off steps to your quality processes, assign default owner and proxy approvals on behalf of unavailable team members. Arena Quality approval processes provide flexibility, control and traceability.
- Provides visibility to all quality issues by linking these to the affected areas of the product record. Ability to add items to Arena Quality from the item header makes it fast and easy for engineers to connect their parts to quality concerns with Arena PLM. Connection of quality processes to each other as affected objects makes it simple to move between processes and building quality workflows. Automatic status updates saves process owner work. And all of your quality processes are tied together in one PLM system.
- In contrast to alternative standalone solutions. Arena Quality is uniquely tied to the product record. Moreover, the module's intuitive ease of use and flexibility translates into no training required.
A cloud-based PLM solution connects quality and planning with the product development process to act as one. With this holistic, end-to-end view of quality management, Arena Quality enables companies to deliver high-quality products more efficiently. This seamless integration, coupled with a suite of robust, easy to use features, keeps costs low and productivity high, while accelerating innovation.