May 26, 2022
By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc.
There are more similarities than differences in the ways medical devices are regulated in the U.S. versus their regulation in Europe. But those subtle differences are critical to understand if you plan to market devices in both regions. See how EU and U.S. medical device regulations compare and learn how digitization streamlines compliance in both regions.
May 25, 2022
By Ave Love, Staff Writer, MasterControl
A manufacturing execution system (MES) solution should offer you the best pharma MES functionality in a simplified package to match your current and future manufacturing needs. Beyond that, it should also expand your visibility across critical pivot points throughout your manufacturing operation. Ultimately, it should support your organizational growth. This post discusses how a modern MES achieves these things.
May 24, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
As we cope with the aftermath of COVID-19 in these uncertain times, it’s critical for pharma outsourcers to control the controllable aspects of supply continuity. These three practical steps will prepare pharma CMOs and CDMOs to handle the supply continuity challenges that will inevitably arise.
May 19, 2022
By David Butcher, Staff Writer, MasterControl
For most production environments, the barriers to adopting a traditional manufacturing execution system (MES) have kept many organizations from digitizing and automating their manufacturing environment. However, new manufacturing technologies are providing smarter, faster, and more affordable paperless shop floor alternatives to legacy MES solutions.
May 18, 2022
By Sarah Beale, Staff Writer, MasterControl
For years now, the FDA has observed that ISO 13485 and 21 CFR Part 820 have a great deal in common and largely accomplish the same level of quality assurance. Now the FDA’s working on harmonizing them.
May 17, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Intelligent, connected technologies are transforming the way life sciences companies manufacture and ensure the quality of their products. To stay competitive, companies are taking advantage of advanced tools and new technology-enhanced approaches to quality management. Leveraging the new solutions and enhanced levels of connectivity now available requires that you first understand three foundational principles of fruitful Quality 4.0 initiatives.
May 11, 2022
By Ave Love, Staff Writer, MasterControl
Compliant medical device design is governed by federal regulations along with competitive market needs. The essential aspects of a design control subsystem are outlined here, along with the most strenuous tasks related to design control, including design reviews. Converting from paper or hybrid quality management systems to an automated one can further reduce the challenges related to managing the Design History File (DHF) and help you to be ready for FDA inspections at any time.
May 5, 2022
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
The digitalization of quality processes can bring transformative change to an organization, but doing it right requires a sound strategy. Learn the four steps that form the foundation of a good organizational change management (OCM) plan.
May 3, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
The increasing complexity, diversity, and personalization of pharmaceutical products has prompted companies throughout the industry to reevaluate their quality approaches. Discover how digital EQMS innovations are enabling leaders to overcome modern challenges.
April 28, 2022
By David Butcher, Staff Writer, MasterControl
As the move toward digitizing manufacturing has accelerated, so has usage of the advanced technologies underlying digitization. Some of the most significant shifts include increases in cloud migration and use of advanced technologies in manufacturing operations to leverage digitization and better collect, connect, and contextualize data.
April 27, 2022
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) has long emphasized the importance of the data integrity aspect of current good manufacturing practices (CGMP). Hoping to reduce data integrity violations, the agency drafted a question-and-answer-based guidance to clarify data integrity guidelines.
April 20, 2022
By Sarah Beale, Staff Writer, MasterControl
Quality is an important part of doing business in regulatory environments. Enabling both quality control and quality assurance in an organization is vital. Learn how QA and QC play into quality management and how an enterprise quality management system simplifies them.
April 19, 2022
By David Butcher, Staff Writer, MasterControl
An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Following these six guidelines will help FDA-regulated and ISO-certified organizations optimize their QMS to ensure high-quality products and continuous compliance.
April 14, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Managing corrective actions/preventive actions becomes overly burdensome for pharma companies when quality problems are escalated to CAPA regardless of their impact or scope. Learn a smarter approach that can help your organization avoid CAPA chaos and other obstacles you’ll face along the road to compliance.
April 12, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
You can’t make quality improvements without accurate, current, and meaningful data. But getting access to better process and performance data may require a different approach to quality trend analysis. Learn the answers to three critical questions about trend analysis in quality management.
April 7, 2022
By Sarah Beale, Staff Writer, MasterControl
Computer system validation can drag on for months. However, it doesn’t have to. The FDA has indicated that a risk-based approach would reduce the validation burden while maintaining compliance.
April 6, 2022
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
Digitization enables companies to completely transform their quality processes, but simply going digital is only half the equation. Nancie Celini shows the importance of applying organizational change management and Quality 4.0 principles when implementing a digital QMS.
April 5, 2022
By David Jensen, Staff Writer, MasterControl
Numerous pharma companies are adopting digitization to ensure long-term relevance in the value chain. This post highlights MasterControl’s “The Ultimate Guide to Digitizing Pharma Manufacturing,” which takes an in-depth look at how the industry is transitioning to modernized operations.
March 31, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
If you’re wondering what sets quality assurance apart from quality control, comparing the two functions to the roles in television’s longest-running police procedural may help you understand the distinction.
