What is Arena Quality?
Arena Quality is an improved cloud-based quality solution designed to bring visibility, cross-functional team collaboration, and long-term tracking of quality resolutions to the enterprise’s core. Specifically, it enables companies to create and/or better meet ISO standards, FDA regulations, and a spectrum of other product quality business processes, including; 21 CFR Part 11, NCMR, CAPA, and 8D. And it’s all embedded into Arena PLM for holistic visibility.
Arena has been helping customers deal with their quality issues for over a decade. Arena Quality is built for companies ranging from larger high tech multinational enterprises that need to unify global business units with modern quality methods 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 and projects, including outside links, result in a more comprehensive solution than other quality modules. These other alternatives connect only to parts and assemblies and have to be cross-checked back and against a PLM solution which does not interface with an independent Quality module.
Arena Quality offers medical device and other highly regulated companies a water-tight solution. By integrating quality processes directly with the product record, Arena ensures quality records are captured and maintained to demonstrate adherence to regulatory requirements. With Arena Quality, companies capture a more “complete quality picture,” allowing auditors to quickly and easily verify compliance in context.”
Arena Quality enables every individual in the company to increase quality with an open privilege model which allows all users to initiate and drive the process. The entire team is empowered to promote continuous improvement in the product and the organization. Other solutions restrict collaboration and ownership to a handful of licenses.
The module is completely integrated into the 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.Download Whitepaper
- Contextual link capabilities allow quality processes to be associated to enterprise business systems (CRM, ERP, MES), and other external data sources, such as; legal claims, warranty claims, external audits, field service reports and regulatory databases.
- Searchable quality processes are fully integrated with the product record (including DMR, DHF, quality documents and Quality SOPs).
- Customizable quality process flows for processes like NCMR, CAPA, 8D, and audit tracking, with custom phases and configurable attributes.
- Comprehensive reporting platform delivers quality data company-wide to appropriate statistical tools for auditable analysis.
- Improved time to market — Operations, manufacturing, quality and engineering collaborate to include quality processes proactively in the development cycle, addressing issues up front to speed time to market.
- Higher product quality — Teams build better product in a culture of continuous improvement, where all stakeholders are alerted to new issues in real time and can learn from a documented library of past challenges.
- Reduced costs and higher margins — Quality process improvements in operations, manufacturing and development reduce scrap, rework and labor to improve product margins and maximize return on investment.
- Greater process efficiency — Managers can ensure proper approvals, maintain accountability, and attach tasks to timelines for resolutions by assigning users to direct process or phase responsibility with due dates and email notifications.
- One system — Your processes are always tied in to the most current product record, taking version control issues off the table.
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 is helping companies deliver high-quality products more efficiently, while maintaining their competitive edge. This seamless integration keeps costs low and productivity high, while stimulating innovation.