Arena Solutions today announced the availability of Arena Quality, a new solution that enables the entire discrete engineering and manufacturing team to rapidly identify, capture, collaborate on and resolve product quality problems.
Quality processes are directly connected to the product record in Arena PLM, which provides everyone with complete visibility into quality issues. Engineering, operations and the supply chain can fully participate in problem resolution and learn from experience to drive continuous improvement. And because Arena Quality captures all quality processes in an easily navigated history, customers will always be audit ready for ISO (International Organization for Standardization), FDA and other organizations.
"The new quality module looks like a great tool," said Julie Stringham, document control manager at Pulsar Vascular, an endovascular medical device company. "Finally, we'll have a solution that can make all quality issues visible to the entire company, which is difficult in our current paper-based system."
Capabilities of Arena Quality include:
- Create and customize templates to support quality processes: The solution provides complete control over phases, attributes and terminology to reflect each individual organization's internal quality process. It also eliminates the need to start from scratch; templates get organizations up and running quickly.
- Assign work, collaborate and see progress: Arena Quality makes it easy to assign responsibility at multiple levels, manage schedules, track progress and drive to final resolution. Quality processes are readily visible in the product record, making everyone aware of outstanding issues. Emailed notifications are shown in the Arena PLM dashboard.
- Explicit phase closure with 21 CFR Part 11 compliant electronic signatures: There's no need to print and manage hard copies. Arena's electronic signature capability has final sign-off covered.
- Persistent history: A complete history of quality processes, down to field level edits, is captured in Arena Quality for audit needs.
"We succeed when our customers succeed, and there are few things more important to our customers' success than producing a high quality product," said Steve Chalgren, Arena Solutions' vice president of product management and strategy. "Because we've made quality a visible and integrated part of the product design and delivery process, everyone in the organization can work together to identify and solve problems quickly."
