THE SOLUTION
Having prior experience using Arena QMS, Mr. Banerjee knew that Arena was the right fit for the company, stating: “Arena QMS is a true lifecycle management system that is better than the typical document-focused QMS solutions I have experienced. Being able to manage BOMs and changes along with quality processes is a major advantage.”
Also, as a cloud-based system, Arena QMS didn’t require a huge IT infrastructure investment or a lengthy implementation. “We started engaging with Arena Solutions in January and by March we were live using the system,” said Banerjee. “We’re using Arena for all training management, supplier management, design controls, engineering change management, regulatory compliance, quality records, and operations processes.”
Arena QMS connects quality records directly to the product design in a single system. This allows Accuryn to document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and nonconformance reports (NCR) in context to the entire product record and BOM. “We have all the phases of design and development managed in Arena QMS,” stated Banerjee. “This includes secure access for our suppliers, which are located globally, allowing them to be notified immediately of any change and ensure their system is up to date.”