ARENA QMS

UNIFIED PRODUCT AND QUALITY PROCESSES

Executive Stakeholders
Speed time to value and ensure strategic product goals are met with a single source of truth

Quality Control
Cultivate a proactive quality culture of process automation, evaluation, and improvement

Engineering
Improve innovation, quality, and design with input from extended product team, product transparency, and product quality control

Operations
Streamline new product introduction and eliminate production mistakes with access to the product record

Reduce cost and improve quality by reporting production problems

Training Manager
Simplify training record administration, access, and traceability

Supply Chain
Gain insights and take actions to improve quality and reduce risks

Bring partners into product realization processes

Customer Service
Accelerate complaint processes for improved customer satisfaction

Purchasing
Factor COGS data into product team design decisions for accurate price negotiations and faster fulfillment

IT
Eliminate upgrade, disaster recovery, and backup activities

INDUSTRY STANDARD

92% of top EMS providers in the industry access Arena customer systems for product collaboration

Ensure Compliance and Exceed Product Quality Goals

	Key Benefits	What Product-Centric Quality Management Does	Quality System Requirement
			FDA	ISO
	Compliant Device Master Record	Controls entire product record, all components, approved manufacturer lists, user documentation, labeling and packaging specifications, manufacturing and test instructions	Design and Document Controls	Medical Device File
	Reduced Design History File Administration	Manages changes to design plans and documentation Contains necessary records to demonstrate compliance with FDA Design Controls regulations	Design and Document Controls	Control of Design and Development Changes
	Collaborative Quality Processes	Provides complaint, CAPA, and ECO processes compliant with corporate, ISO (9001, 13485), FDA (21 CFR 820), EU MDR, and other regulations	Corrective and Preventive Action, Nonconforming Product	Quality Processes
	Employee Competence and Awareness	Notifies employees for scheduled retraining events and training triggered by a document release Automatically creates new training assignments when a new document revision is released to streamline training processes regulations	Personnel	Human Resources
	Audit Confidence	Collects compliance evidence with time-stamped audit trails and electronic signatures on product and quality processes Provides searches and logically connected product and process information	Audit Support, 21 CFR Part 11	Audit Support
	Streamlined Supplier Quality Management	Manages supplier standards, evaluations, and agreements and quality processes for purchased parts and suppliers	Purchasing Controls	Purchasing Process
	Secure Product and Process Data	Ensures access is granted only to those with proper security access control	N/A	Control of Records
	Accelerated System Validation	Arena performs installation and performance validation prior to each release	Production and Process Controls (Automated Processes)	Validation of Processes for Production
	Traceability in Issue Handling	Tracks issues against requirements, quality process actions, product record components, and project efforts	Nonconforming Product	Product Realization
	Verify and Validate Design Requirements	Provides connected and visible requirements management throughout product lifecycle	Design and Document Controls	Product Realization

Go Beyond Compliance to Great Products

Arena offers the most comprehensive product-centric QMS to help you innovate rapidly. We improve, accelerate, and track your product processes across multiple teams, locations, and partners using compliant processes. We help your teams collaborate through the entire product lifecycle, stay on budget, and respond effectively to customer demands. All of this helps you bring better regulated products to market, faster and easier, so you can change the world.

To find out how you can join some of the most innovative customers in the world, contact [email protected].