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.
March 30, 2022
By Sarah Beale, Staff Writer, MasterControl
The ultimate responsibility in a business lies at the top. In the regulatory world, this includes ensuring the quality system of a medical device company is effective. The specifics of how and how often the review should be conducted are a bit hard to pin down, but that’s by design. 21 CFR Part 820 has general guidelines, but leaves much of the “how to” up to individual companies.
March 29, 2022
By David Jensen, Staff Writer, MasterControl
Lately, it seems the only other term uttered as often as COVID-19 is supply chain. Global supply chains are largely becoming more complex, difficult to manage, and vulnerable to uncertainties and risks. This post addresses the supply chain challenges for pharmaceutical companies and provides tips for overcoming them.
March 24, 2022
By David Butcher, Staff Writer, MasterControl
Even as new technologies provide life sciences manufacturers with smarter, faster, and more cost-effective ways of improving production, choosing the right manufacturing software to transform production processes can be challenging. By determining the capabilities that fundamentally complement an organization’s quality manufacturing goals and current practices, manufacturers will be better prepared to choose the modern manufacturing execution software tools they need to succeed.
March 23, 2022
By Matthew Kanter, Associate Consultant, MWA Consulting, and Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences
With the significant advances in gene and cell therapies, companies producing breakthrough products are facing obstacles ranging from challenges with development to transitioning to commercial manufacturing. Solutions can be found in digital manufacturing execution systems (MES) and quality management systems (QMS).
March 21, 2022
By Steve Holbrooks, Project Manager, MustardSeed
Pharma manufacturers that adopt machine vision technologies are finding faster ways to detect and contain defects and avoid waste and rework. Learn why automated visual inspection (AVI) systems are the key to enhancing quality and productivity in evolving manufacturing environments.
March 18, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.
