INDUSTRIES WE SERVE

Designed for Complex
Technology Products

BIOTECHNOLOGY

Simplify Your Audit Processes

With breakthroughs in personalized medicine, genomics, and medical devices, biotechnology companies are finding new ways to advance human health. Yet progressive competition and increased global regulatory requirements make it challenging to launch safe and high-quality products on time.

Arena’s product-centric quality management system (QMS) helps biotechnology companies overcome obstacles to deliver rapid breakthroughs and safer products.

INDUSTRY CHALLENGES

Arena QMS addresses these key challenges:

Disconnected systems limiting visibility into quality and product information
Establishing controlled product development processes to ensure regulatory compliance
Managing quality system information to show evidence of compliance
Communicating with external suppliers and outsourced manufacturing partners

HOW WE HELP

Arena QMS benefits include:

Improving design controls for design history files (DHFs) and device master records (DMRs)

Connecting quality processes directly with the product record to increase visibility

Ensuring compliance to FDA and ISO standards

Passing audits with traceable records throughout NPD and NPI

Enabling secure, controlled collaboration with supply chain partners

Reducing quality issues, product costs, and production delays

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CUSTOMER SUCCESS

Pulse Achieves Closed-Loop Design Control Across the Organization

“Arena makes the whole product process much faster and efficient. Arena helps us with DHF, project management, supplier management, CAPA, all our quality actions like NCMRs, change control, of course, and management of training.”

– Guneet Bhogal, Quality Assurance Specialist, Pulse Biosciences

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