GxP Lifeline

3 Characteristics of Successful Quality 4.0 Initiatives

May 17, 2022 By James Jardine, Staff Writer, 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.
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Alleviating Headaches From 21 CFR 820 Design Control Compliance

May 11, 2022 By Ave Anderegg, 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.
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The CAPA Magnificent Seven

May 10, 2022 By Sarah Beale, Staff Writer, MasterControl

Learn about seven ways to simplify your CAPA process by taking a closer look at the 1960s classic “The Magnificent Seven.”
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OCM and eQMS: Transformation or Conformance?

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.
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How Modern EQMS Solutions Are Powering Pharma’s Digital Revolution

May 3, 2022 By James Jardine, Staff Writer, 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.
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Medical Device Manufacturing Trends, Pt. 2: Digitize to Make Data Usable

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.
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FDA Guidance Assists With Preventing Data Integrity Violations

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.
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The EQMS for Your Quality Assurance and Quality Control Systems

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.
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6 Ways to Ensure Your Quality Management System Meets FDA and ISO Compliance

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.
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CAPA Overload and Other Perils to Avoid on Your Compliance Journey

April 14, 2022 By James Jardine, Staff Writer, 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.
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Quality Trend Analysis: Improving Decision-Making With Timely Data

April 12, 2022 By James Jardine, Staff Writer, 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.
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5 Answers to FDA Computer System Validation Questions

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.
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OCM and a Digital QMS: Your Combination for a Competitive Edge

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.
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Ultimate Guide Spotlights Pharma Manufacturing’s Transition to Digitization

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.
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Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

March 31, 2022 By James Jardine, Staff Writer, 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.
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Quality Management Review for Compliance and Improvement

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.
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Pharma Supply Chains Call for Better Visibility

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.
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5 Key Areas for Life Sciences Manufacturers to Prioritize in Manufacturing Software

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.
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Quality and Manufacturing System Implications for Cell and Gene Therapy

March 23, 2022 By Matthew Kanter, Associate Consultant, MWA Consulting, and Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc.

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).
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Automated Visual Inspection Delivers Transformational Improvements in Pharmaceutical Manufacturing

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.
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