Training management, in the context of the FDA, requires that medical device manufacturers train employees regarding policies, standard operating procedures, and related work instructions required for each employee’s role. Organizations must document and demonstrate that employees are able to meet the requirements of their roles. ISO 13485:2016 further requires the demonstration of competency. A training management system enables an organization to effectively track, train, and ensure compliance to all required policies and procedures.
A training management system enables you to efficiently manage employee training plans and records from a single centralized system. It ensures that employees are trained and competent to complete their job responsibilities.
A training management system enables organizations to:
Training record management is a requirement of quality management, compliance, and regulatory practices and critical to employee safety.
Managing training in spreadsheets can present compliance risk and costly penalties. Learn the seven benefits of automating your training record management.
Arena PLM software streamlines product development so you can deliver products under budget and ahead of schedule.
Arena QMS helps you ensure regulatory compliance and faster delivery of life-enhancing products to your customers.
