Content by Stephanie Ojeda
Thu, 07/13/2023 - 12:03
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.…Thu, 06/29/2023 - 12:03
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.
It’s also critical to ISO 9001, FDA Quality System Regulation (QSR), and EU Medical Device…Tue, 05/02/2023 - 12:03
Quality management and environmental health and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces that have shaped quality and safety during their history.
Modern…Thu, 12/08/2022 - 12:02
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial…