Content by Stephanie Ojeda
Understanding the Differences Between Deviation and NonconformanceCreate clear definitions within your workplace and keep up with standard practices
Wed, 04/16/2025 - 00:02
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed. This article explains the difference…
Enhancing Compliance Through Quality Risk ManagementBuilding resilience and reliability
Tue, 03/18/2025 - 12:03
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820…
Apply AutomationHow to achieve manufacturing quality compliance success
Thu, 01/30/2025 - 00:02
The U.S. Food and Drug Administration’s inspections and subsequent actions all come down to product quality. Quality system failures result in noncompliances that FDA inspectors target during their inspections. If there is any doubt that a…
AI in Medical Device ManufacturingAnd how it’s transforming an industry
Wed, 01/29/2025 - 00:01
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss. Since then, the industry has seen explosive growth of…
How Technology Supports ALCOA PrinciplesQuality management software strengthens data integrity in life sciences
Tue, 11/12/2024 - 12:02
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and…
Ways to Influence Stakeholder Buy-In During the CAPA ProcessA collaborative approach is most effective
Tue, 09/24/2024 - 12:02
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the corrective and preventive action (CAPA) cycle? With the burden of quality and compliance on their shoulders, it…
Twelve Strategies for Successful CAPA ManagementHow well you manage CAPAs shows well you manage quality
Thu, 08/01/2024 - 12:03
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system. CAPA management is a recurring theme in U.S. Food and…
Customer Quality ManagementHow a QMS can help
Wed, 07/10/2024 - 12:03
Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes…
The Power of Change Management ToolsPreparing employees, teams, and systems for new ways of working
Wed, 06/19/2024 - 12:02
Look through even a few FDA warning letters and you’re likely to find violations related to change management. For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug…
Guide to Choosing the Right Training Management SoftwareLook for a system that supports compliance with regulatory and standard requirements
Wed, 04/24/2024 - 12:02
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations. It’s one of several factors motivating companies to switch…