Stephanie Ojeda

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

Thu, 10/31/2024 - 10:16
Risk Management in ISO 13485The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Tue, 11/07/2023 - 11:03
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO…
Aligning Incident Management With ISO 45001 RequirementsIncorporate risk-based thinking in your approach
Wed, 10/04/2023 - 12:03
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey. This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core…
EHS Incident Management and Root Cause AnalysisSolve problems better, faster, and with greater confidence in your operations
Wed, 09/13/2023 - 12:02
Untitled Document Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety. There are also…
Managing SOPs With the QMSCommon mistakes and best practices for your quality management system
Wed, 08/02/2023 - 12:03
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today. Consider, for example, an electronics manufacturer that introduces a new product model with updated…
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…