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GxP Lifeline
  • Image of MasterControl’s infographic on FDA product recall prevention.

    4 Keys to Effective Product Recall Management

    Even the slightest quality failures can lead to product recalls. Keep your guard up against recalls by learning about their primary causes, how the FDA classifies them, the four critical steps of recall response, and smart approaches that can help you avoid them altogether.

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  • MasterControl’s ultimate guide to FDA Recalls for Life Sciences Companies

    FDA Product Recalls: Understanding the Risks and Solutions for Life Sciences Manufacturers

    With a 115% increase in FDA recalls since 2018, it's clear that life sciences companies need to take proactive measures to protect their products, reputation, and bottom line. This blog post explores the causes of recalls, their impact on consumers and businesses, and how connected digital solutions can help you prevent them.

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  • Image of a digital MES in a life sciences manufacturing environment.

    Hardware That Works: How to Choose the Right Tools for Your Life Sciences QMS and MES

    Selecting the right hardware to support QMS and MES software solutions is a critical step life sciences manufacturers often overlook. Since it’s easy to be overwhelmed by the variety of hardware options available, DTG CEO Stephen Shaheen examines how to simplify those choices using a targeted and systematic approach.

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  • Image of a life sciences lab professional looking down a microscope.

    Navigating the FDA’s Final Rule for Laboratory-Developed Tests (LDTs)

    Nervous about changes to the regulation of laboratory-developed tests (LDTs)? This blog post provides an in-depth analysis of the FDA’s final rule, outlines the history and context of LDT regulation, and highlights the phases of implementation, challenges, and opportunities for laboratories and manufacturers.

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  • Image of a life science manufacturing professional checking an FDA product recall checklist.

    FDA Compliance and Product Recall Prevention Checklist

    When FDA investigators identify issues that could potentially lead to product recalls, they typically stem from quality failures like inadequate documentation, poor quality event management, and insufficient process validation. Find out how you can effectively address these vulnerabilities and significantly reduce the risk of an FDA recall.

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  • Image of a life science manufacturing professional using AI for their GxP Compliance efforts.

    GxP Approaches for Data Infrastructure and AI

    This blog post shares some of the challenges, opportunities, and best practices for building a robust data platform that will enable AI in a way that supports GxP compliance. Discover why it comes down to data availability and infrastructure to ensure that your models are reliable, secure, and easily accessible for regulatory scrutiny.

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  • Image of life science manufacturing professional working on their quality management validation process on their laptop.

    Validation 4.0: How AI Is Transforming Life Sciences Quality Management

    All the buzz around AI has life sciences companies wondering how emerging technologies can be applied to advance validation processes and improve quality management. VEQTOR’s team examines ways generative AI can be put to work to make real-time verification and seamless integration with digital ecosystems possible.

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  • Image of life sciences lab sales and quality professionals working together and looking at a computer screen.

    Uniting Sales and Quality in Life Sciences: A Recipe for Success

    The relationship between quality and sales team is not only crucial, but it can transform a company and drive unprecedented successes. Lotus Business Solutions’ Christina Pecoraro examines how this relationship can result in more positive customer experiences and company growth.

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  • MasterControl’s infographic “Your Guide to FDA Product Recall Avoidance"

    FDA Product Recall Avoidance: Your Guide to Preventing Regulatory Pitfalls

    With FDA product recalls on the rise, life sciences companies need help navigating the intricacies of regulatory compliance and quality management. This blog post provides recommendations to help manufacturing and quality professionals effectively manage product quality issues, avoid receiving FDA Form 483 observations, and proactively prevent recalls.

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  • Image of a pharma manufacturing technician working.

    Aligning Internal Procedures With ICH Guidelines: Challenges and Solutions for Pharma Manufacturers

    Navigating ICH guidelines presents significant challenges for pharmaceutical manufacturers. This blog post explores the key difficulties in interpreting guidelines, adapting existing systems, and ensuring consistent application across departments. It offers practical solutions, emphasizing the role of modern pharma QMS software in overcoming these hurdles. Discover how leveraging technology can streamline compliance efforts, drive operational efficiency, and improve product quality.

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  • Image of a pharma manufacturing technician using a digital manufacturing software.

    From Error to Excellence: Why Pharma Manufacturers Need to Embrace Digital Maturity

    As quality and compliance standards in pharma become higher and stricter, the shift from error-prone manual processes to operationally robust, fully digitalized processes can no longer be considered optional. Elemental Machines’ Dan Petkanas explains why it’s critical for pharma manufacturers to embrace digital maturity.

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  • Life science manufacturing professional touching a digital QMS

    Elevate Your Life Sciences QMS: 5 Must-Have Features

    As life sciences companies grow and evolve, their quality management systems (QMS) must keep pace. A QMS that was once good enough to get the job done might now be hindering your operations. Learn the five signs indicating it's time for a QMS upgrade.

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  • Image of FDA product recall.

    Your Guide to Avoiding FDA Product Recalls: A Lifesaver for Life Sciences Companies

    The fallout from FDA recalls can be profound, leading to massive financial losses, reputation damage, and even legal consequences. Find out what the new “Ultimate Guide to FDA Product Recalls” says about the upstream impact of recalls and how life sciences companies can prevent them.

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  • Image of a team of pharma manufacturers using digital MES.

    The ROI of Pharma MES: How Investing in cGMP Compliance Saves You Money

    Discover how investing in a pharma MES can significantly improve your ROI by streamlining cGMP compliance efforts and minimizing hidden costs. Learn about the benefits of automating key processes, reducing errors, and streamlining audits. Download our free Manufacturing Software Buyer's Guide to learn more and start exploring how MasterControl MES can transform your operations.

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  • Success With AI in Life Science Manufacturing Requires Humans in the Loop

    Generative artificial intelligence (AI) tools aren’t intended to replace humans. Rather, they’re designed to assist and augment them. Learn the benefits of taking a collaborative approach to using AI and how modern tools like MasterControl’s Exam Generator let humans actively guide and refine AI output.

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  • Image of MasterControl’s survey on FDA product recalls and its impact on life sciences manufacturers.

    FDA Product Recalls: A Wake-Up Call for Life Sciences Manufacturers

    A new MasterControl survey report on FDA product recalls highlights the disconnect between consumer awareness and action, how recalls erode trust in life sciences manufacturing processes, generational differences in recall responses, and strategies for rebuilding trust. Take a deep dive into the report’s examination of the long-term impacts of recalls and learn why effective product recall management is essential for companies to maintain consumer trust and protect brand reputation.

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  • MasterControl’s recent webinar on the benefits of implementing a connected QMS and MES platform in life science manufacturing.

    Revolutionizing Life Science Manufacturing: The Benefits of a Unified QMS and MES Platform

    Nothing is more important to manufacturers in the life sciences than ensuring product quality. Learn how integrating QMS and MES in a single platform helps life science manufacturing organizations improve product quality, achieve greater efficiency, and accelerate regulatory compliance.

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  • Image of medical device manufacturing professional holding a virtual pen whilst working on transitioning to QMSR.

    3 Simple Steps to Transition to QMSR

    Many medical device companies are wondering how the FDA’s Quality Management System Regulation harmonization will impact their quality management systems. No matter the complexity of your QMS or medical device, here are three simple steps device manufacturers should take to simplify the transition to the QMSR.

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  • Image of a medical devices manufacturing professional working with a QMS software

    How a Device Developer Transformed Quality Management With an Integrated QMS

    How can medical device companies evolve and grow in the increasingly complex world of compliance and technology? Find out how Veranex overcame regulatory and efficiency challenges by implementing an advanced quality management system.

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  • Pharma manufacturing professionals working with a QMS system.

    Is Your Pharma QMS Equipped to Handle Risk?

    Managing risk is challenging in the evolving pharma landscape. Discover how a proven quality management system can help pharmaceutical companies overcome common risk management challenges and achieve operational excellence.

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