Stephanie Ojeda

Stephanie Ojeda is the director of product management for the life sciences industry at AssurX.

Mon, 06/16/2025 - 13:34
Linking Design Controls and Risk Management in the QMSAutomation maintains a living document and integrates risk management
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.…
Improve Complaint Management for Life Sciences With an Automated QMSWays to stay compliant while reducing risks to patients
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…
Why Manufacturers Are Integrating EHS and QualityWhat’s driving the shift, and what are the potential benefits?
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…
Eight CAPA KPIs You Should Be Measuring NowCompanies should track a range of CAPA metrics
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…