Product-Centric QMS: A Critical Advantage for Regulated Companies Confirmation

FDA regulated companies must establish quality systems for compliance. Most quality management systems (QMS) were developed to help comply with regulations with a sole focus on automating the paper-based processes.

However, complex product companies realize that document-centric QMS systems fail to capture the comprehensive product record. Medical devices that are comprised of mechanical, electrical, software, assembly and test procedures, and other documentation necessary to design, produce, and improve innovative products require a more comprehensive solution.

Arena’s product-centric approach enables medical device companies of all sizes to optimize quality management in the context of managing the entire product record. Arena’s entire product record is linked to CAPA, engineering changes, and other product-driven processes.

In this white paper, find out how Arena:

Provides corporate wide visibility of full product records & associated processes

Enables enterprise & supply chain collaboration

Offers a closed loop corrective action preventive action (CAPA) process

Simplifies enterprise software system validation

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The main goal of PLM implementations is to streamline and align business processes. With a successful PLM implementation, you'll improve communication track product records, button down and collaboratively share all changes and have a single version of the truth. Knowing the top PLM best practices for implementation can make the most of your PLM investment. Download this white paper today.

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