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GxP Lifeline
  • Strategic Supplier Quality Management: Navigating Risks, Ensuring Quality in Life Sciences

    Effective supplier management is a linchpin for success in dynamic industries where product quality and regulatory compliance are non-negotiable. In this blog post, Avendium CEO Lars Mouritsen outlines the nuanced strategies and key components necessary to ensure a seamless and reliable supply chain.

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  • Quality First: Consumer Product Recalls Have Risen 115% Since 2018

    In highly regulated industries like food, drugs, and medical devices, manufacturing companies must make big investments in people and products so they can avoid costly and damaging recalls. Find out why product recalls have spiked significantly in the past few years and what that means for manufacturers and consumers alike.

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  • The Crucial Role of Production Planning in Medical Device Manufacturing

    In highly regulated environments, the effectiveness of a medical device product plan is often ignored – to manufacturers’ detriment. Learn how modern digital tools give manufacturers the power to not only ensure their medical device product plans are transparent and efficient, but also traceable and compliant.

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    5 CAPA Best Practices for Life Sciences Manufacturers

    Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.

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    Deviation Management Tips for the Digital Era

    Deviation management can be challenging – especially if your systems and processes aren’t connected. ELR Lab Services’ Erika Roberts offers a few tips on how to make managing deviations easier.

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    Practical Steps for Jumpstarting Your Digital Transformation Journey

    If you’re preparing to digitize manufacturing processes, the smartest approach is to learn from trailblazers’ experience. Read a recap of a conversation between Aspire Pharma’s VP of quality and Elemental Machines’ founder that shows how modern integrations are paving the way for comprehensive and transformative digital shifts in manufacturing.

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    Improving Compliance and Effectiveness Through Leaner Documentation

    Process nonconformances often just seem to lead to longer, more prescriptive, and more complex documents. But longer and more complex doesn’t mean better. QRx Partners’ Steve Gompertz examines the many benefits that can be gained by taking a leaner, process-focused approach to documentation.

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    World Quality Week Is Your Chance to Celebrate Quality

    This year’s World Quality Week, Nov. 6-10, offers the opportunity to realize your competitive potential. Join us in celebrating the masters of quality and sharing a few laughs about quality management professions.

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    New Paradigm for Quality Event Management Unveiled at Masters Summit

    Quality professionals are all too familiar with having to shoehorn their organizations’ processes to fit the rigid functionality of their software systems. But those days are coming to an end. Find out how a revolutionary new tool is going to give quality leaders unprecedented control and forever change the way they manage quality events.

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    5 Ways to Eliminate the Hassles of Batch Records

    Digital manufacturing solutions, such as modern electronic batch records (EBRs), are key to optimizing your entire manufacturing operation and production staff. This post addresses key aspects of a good digital manufacturing solution and offers tips on choosing the right system.

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    Why Document Control Is a Catalyst for Digital Transformation

    All developers of regulated products know that every aspect of product development and manufacturing must be documented. To regulatory authorities, if it isn’t documented it didn’t happen. This post addresses regulatory oversight of documentation and identifies how document control software is a good springboard for a full digital transformation in quality management.

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    Ensuring Excellence: The Importance of Vendor and Supplier Quality Management for Life Sciences

    Quality and safety are the most important attributes of any product developed and sold by life sciences manufacturers. And supplier quality management plays a key role in ensuring both. In this blog post, Avendium CEO Lars Mouritsen examines the importance of supplier quality management, best practices, and its considerations and consequences in life sciences industries.

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    Why Choose a Configurable Quality Event Management Solution?

    What will the digital landscape for quality professionals look like five years from now? Most likely, it will be centered on empowered quality professionals. Find out how configurable quality event management solutions are changing the face of quality by allowing quality professionals to capture and scale their expertise.

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    Clearing the Hurdles to Digital Manufacturing

    Research shows that both real and perceived obstacles are standing in the way of life sciences companies’ efforts to transition to digital manufacturing operations. While there may be a variety of blockers to digitization, there are ways to overcome them and improve operations. This post addresses the common obstacles to digitization and strategies for getting past them.

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    Why Accountability Is the Foundation of a Culture of Quality

    A growth-oriented mindset facilitates trust and respect between quality and manufacturing teams. Find out how feedback and accountability lay the foundation for a culture of quality in life sciences organizations.

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    Gaps in Quality Audits: 5 Things Every Auditor Should Do

    Any decision made about a product is based on data, which means data errors and omissions can have significant negative impact. In this article, KPI System CEO Rai Chowdhary illuminates the need for more rigor on auditing of data, its analytics, and application of statistical methods.

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    Keys to Overcoming Common Recipe Management Challenges

    Success in pharma manufacturing hinges on effective recipe management. This blog post examines the challenges associated with recipe management in manufacturing and shows how modern digital manufacturing solutions can streamline processes, ensure compliance, and drive operational excellence.

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  • 2023-bl-gxp-lifeline-csa-vs-csv_132x132

    CSA vs. CSV: FDA’s Computer Software Assurance Draft Guidance for Production and Quality System Software

    There are many views about what the FDA’s recent draft guidance on computer software assurance (CSA) means and how compliance with it differs from traditional approaches to computer software validation (CSV). Arbour Group’s Rahul Kallampunathil offers an in-depth look into what CSA entails and the benefits it provides.

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    Maximizing Manufacturing Efficiency and Quality With Digital Work Instructions

    Nothing is propelling efficiency in manufacturing like modern digital tools. This blog post examines the impact of digital work instructions in manufacturing, the increasingly important role of manufacturing work instruction software, and how these modern solutions fit into the broader manufacturing execution system (MES).

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    AI in Quality Management: A New Age for Document Search

    Artificial intelligence is revolutionizing the management of quality documentation. Botable CEO Greg Waldstreicher examines how AI is reshaping quality documentation search and explores the AI-driven future of quality management.

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