Go Beyond the Limitations of Document-Centric QMS Approaches

Simply Put, Document-Centric QMS Falls Short

For medical device companies, document control is critical to success. Despite that absolute, traditional stand-alone QMS systems address only a subset of what’s needed, focusing only on two fundamental areas of FDA compliance:

1. Documentation control for SOPs, specifications, and other files
2. Process enablement and tracking for auditable processes (including CAPA, requirements management, and training records)

While the automation of paper-based processes is helpful, that function alone fails to capture or connect quality management processes to the comprehensive product record often comprised of hundreds if not thousands of mechanical, electrical, and software components; assembly and test procedures; and other documents specified in a product’s bill of materials (BOM).

Traditional document-centric QMS approaches may suffice for some life sciences companies that don’t have complex products. However, medical device companies that develop products with a mix of electrical, software, and mechanical components must bring crossfunctional teams and designs together to prevent product issues from arising too late in the NPI process. They must also provide traceability between all aspects of the design and quality elements and be able to track, control, and release product design changes to market quickly and effectively. And, they must be able to address product failures to identify, analyze, and resolve issues. Let’s look deeper. Read more about Determining the right type of quality management system for your needs.

Realize the Benefits of Product-Centric QMS

While still providing the benefits of automated document management, a product-centric approach to QMS is advantageous because it enables complete control throughout your new product development and introduction (NPDI) process.

Arena QMS achieves this by aggregating the entire product record and connecting it to quality processes within a single system. At the heart of every medical device company’s product is a complex, relational BOM specifying hundreds or thousands of interrelated components, subassemblies, and associated documents required to test, build, and ship your products to market. This approach addresses quality system requirements in a more traceable, controlled, and connected manner allowing all teams to view the design and related quality records without having to refer to multiple disconnected systems.

The benefits are significant:

• Acceleration of your product launch process
• Streamlined regulatory compliance
• On-time shipment of reliable, high-quality products
• Tighter control of your product design
• Reduced costs and improved compliance
• A common platform enabling cross-functional team collaboration and continuous improvement