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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.
Arena QMS addresses these key challenges:
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
Passing audits with traceable records throughout NPD and NPI
Reducing quality issues, product costs, and production delays
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
