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 biotech companies overcome obstacles with:
- Disconnected systems limiting visibility into quality and product information
- Establishing controlled product development processes to ensure regulatory compliance and safety
- Managing quality system information to show evidence of compliance
- Communicating with external suppliers and outsourced manufacturing partners
- Improving design controls for design history files (DHFs), device master records (DMRs), training records, SOPs, and CAPA processes
- Connecting quality processes directly with the product record to enable visibility and cross-functional collaboration
- Ensuring compliance to FDA and ISO (e.g., 21 CFR Part 11, 21 CFR Part 820, ISO 13485)
- Passing audits with traceable records throughout NPD and NPI
- Enabling secure, controlled collaboration with external supply chain partners
- 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 BiosciencesSee Pulse Biosciences Success Story