Stephanie Ojeda

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

Thu, 12/08/2022 - 12:02
Top Considerations for Compliance Management ToolsA catalyst for improved quality and compliance
Thu, 03/21/2024 - 12:02
Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully. Get it right and you could save thousands of labor hours, avoid…
Nine Strategies for Effective Internal AuditsMaking sure critical issues see the light of day
Mon, 03/11/2024 - 13:03
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.” In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the…
The Hidden ROI of Complaint ManagementHow addressing customer concerns benefits the entire quality process
Wed, 02/28/2024 - 12:03
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations. The FDA mandates that medical device companies, for…
The Importance of a Document Management SystemWithout it, manufacturers face risks of recalls, compliance issues, and lower productivity
Mon, 12/18/2023 - 12:02
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen. In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective…
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…