Do you see Quality Management Through a ‘Product’ Lens?
The Problem We Solve
Some life sciences companies can get by with document-centric QMS solutions. However, life science companies with mechanical, electrical, and software components require a product-centric QMS approach to connect the entire product record to training, CAPA, and quality records. Leveraging a single system of record to manage the product and related quality processes simplifies compliance and speeds time to market.
What We Do
Our product-centric QMS solution streamlines product realization processes with links to relational bills of materials (BOMs), engineering changes, and quality records to eliminate disconnected silos. Arena’s comprehensive quality management system improves management of Standard Operating Procedures (SOPs), Device Master Records (DMRs), and Design History Files (DHFs) to simplify compliance and reduce audit risks.
One Solution is Better Than Two
Document-centric QMS systems were not designed to manage complex BOMs with hierarchical records that include electronics, software, and hardware. Without control of the entire product and quality record in a single solution, companies are more likely to experience development and shipping delays, excessive scrap, and costly rework. Arena QMS was designed to streamline new product development (NPD) and new product introduction (NPI), while enabling regulatory compliance.
Arena’s comprehensive QMS solution helps manage:
- Documents, parts, training records, engineering changes, projects, specifications, SOPs, DHFs, DMRs, and CAPAs
- Relational BOMs with mechanical, electrical, software, and documents
- Upstream and downstream integration to CAD, CRM, and ERP systems
- Relationships between product, changes, training, and quality records
- Manufacturers and suppliers information (AML / AVL)
- Quality and product process analytics
- Standards and regulatory compliance including ISO 13485, FDA Title 21 CFR Part 11 and Part 820
Document-centric QMS solutions require separate product management solutions requiring duplicate data entry. This results in data synchronization issues and confusion regarding where the latest product or quality information can be found. Arena eliminates the need for traditional stand-alone QMS systems.
For medical device companies, it is critical to have a quality system with a solid, connected product realization platform. Arena’s multi-tenant cloud solution streamlines product development and quality to give increased visibility and control to internal teams and external partners.
With Arena QMS, customers gain these strategic benefits:
- Faster time to market
- Improved product quality
- Reduced costs and higher margins
- Increased innovation
- Fewer compliance issues and nonconformances
- Enhanced visibility of product and quality processes
Simplify and Maintain Arena Software Validation
Spend less time validating Arena with our complete package of requirements, impact analysis, protocols, execution records, reports, and validation knowledge base experts.
Software applications must be upgraded to meet your expanding business requirements, new technology, and industry demands.
Arena Validation Maintenance Service (VMS):
- Enables you to spend more time on your core competency—and less time validating Arena
- Provides faster compliance for your initial system implementation
- Includes validation services with every future software release
“Arena gives us the ability to manage our quality processes and our product all in one solution. We have gone from a paper based to electronic management solution for several different processes. In addition to change control and BOM management, we have implemented several different quality processes including CAPAs, nonconformances and our entire supplier management process.”
“Although the Arena team was not involved in our FDA inspection, your solution helped us find and retrieve records quickly to address inspection requirements ahead of schedule. Thank you for supporting our needs and creating a solution that really works as promised!”
“Implementation was made very easy by Arena by giving us complete IQ and OQ documents. The wide range of standard out of the box functionality narrowed the scope of our work even more. This resulted in a very productive and complete PQ while requiring much less management than other IT system implementations I have been a part of.”