Arena Solutions, a cloud-based product lifecycle management (PLM) applications provider, has unveiled Arena Quality, a new quality management module for its Arena PLM system. This module allows for discrete engineering and manufacturing teams to rapidly identify, capture, collaborate and resolve product quality problems, the company states.
Integrated into Arena PLM records and processes, the Arena Quality module, says the company, ensures that engineering, manufacturing, quality and supply chain teams have in-context visibility to all quality issues as they design, review, improve and build products. Arena Quality helps companies create and/or better meet ISO standards, FDA regulations and other product quality business processes such as 21 CFR Part 11, NCMR, CAPA and 8D, adds the company. Additionally, because Arena Quality captures all quality processes, customer records should always be audit-ready, says Arena.
Arena Quality’s contextual link capabilities also allow quality processes to be associated to enterprise business systems (Customer Relationship Management, Enterprise Resource Planning, MES) and other external data sources, such as legal claims, warranty claims, external audits, field service reports and regulatory databases. Quality processes also are searchable.
In its announcement of Arena Quality, the company highlighted several capabilities, including:
- Create and customize templates: This capability is said to provide complete control over phases, attributes and terminology, enabling users to reflect their organization’s quality processes.
- Assign work, collaborate: Arena Quality can help managers assign responsibility at multiple levels, manage schedules and track progress. Email notifications display on the user dashboard, and quality processes are in a visible product record.
- Explicit phase closure: This feature comes with 21 CFR Part 11 compliant electronic signature, so staff can simply use digital copies for forms.
- Persistent history: A complete history of quality processes, down to field level edits, is available.
“We know our customers have teams who are dedicated to constantly drive for continuous improvement in the design, manufacturing and logistical processes,” said Steve Chalgren, Arena’s vice president of product management and strategy in a press statement. “With [the Arena Quality] solution, Arena makes quality a visible and integrated part of the product design and delivery process, enabling the quality teams to bring everyone together to identify and solve problems.”
The Arena PLM suite of products includes a variety of functional modules for such processes as bill of materials management, change management, demand analysis, document management and supply chain collaboration. Arena Quality will become available later this month, according to the company.
For further details, go to the Arena Quality web page.
Sources: Press materials received from the company and additional information gleaned from the company’s website.