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GxP Lifeline
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    Why Pharma and Medtech Should Digitize Quality in a Down Market

    If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.

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  • 2022-bl-software-validation_132x132

    6 Steps to Simplify Software Validation

    The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.

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  • 2022-bl-mwa-supplier-management_132x132

    The Criticality of Supplier Management and Keys to Improvement

    To ensure you’re able to manufacture high-quality products and safeguard patient safety and data integrity, your organization must be able to effectively manage supplier quality. Find out how taking a risk-based approach and applying modern tools can improve your supplier management capabilities.

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  • 2022-bl-gxp-software-validation-medtech_132x132

    Combatting Counterfeit Medical Devices and Pharmaceuticals: Serialization, Validation, and a Case for Digital Transformation

    Criminal opportunists are making a killing off counterfeit versions of life sciences manufacturers’ products. Learn why serialization is the key to getting fake products off the market and ensuring consumer safety.

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  • 2022-bl-cmo-cgt_132x132

    Modernizing Your Way to Success in Cell and Gene Therapy Manufacturing

    Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.

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  • 2022-bl-embedding-quality_132x132

    Achieving Next-Level Quality With Digital Technology in Manufacturing

    In fully or partially paper-based manufacturing environments, the production line is an underappreciated opportunity to make quality proactive rather than reactive. Digital technology in manufacturing can ensure quality at every step of production.

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  • 2021-bl-matt-lowe_132x132

    FDA’s Newest Medical Device Security Guidance

    As medical devices have grown increasingly complex, the need for cybersecurity guidance has never been greater. The latest guidance from the U.S. Food and Drug Administration provides updates to earlier versions that manufacturers need to know.

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  • 2022-bl-northeast-scientific_132x132

    How Process Digitization Accelerates Northeast Scientific’s FDA Compliance

    When it comes to avoiding FDA Form 483s and getting 510(k) clearance for medical devices faster, Northeast Scientific has cracked the code. Find out how the leader in medical catheter reprocessing has fast-tracked regulatory success and eliminated lag points.

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    Applying Quality System Regulation (QSR) Best Practices to Improve Regulatory Compliance

    Every medical device company is faced with the challenge of navigating the FDA’s quality system requirements. Cannon Quality Group shares four compliance best practices that help make the regulatory road less rocky.

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  • 2022-bl-iso-9001_132x132

    Overview of QMS Change Management in ISO 9001:2015

    ISO 9001:2015 is one of the most recognized standards in the world. Among the goals of the quality management system (QMS) standard is to enhance requirements for addressing QMS change management.

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    3 Ways to Improve QMS Documentation: Following International Standards

    The scope of a quality management system (QMS) can look very different depending on the size and goals of a company. However, following ISO 9001 standards for documentation can benefit any system.

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  • 2022-bl-fda-guidance-data-integrity_132x132

    5 Tips to Avoid FDA Data Integrity Violations

    The FDA is paying more and more attention to life sciences companies data management deficiencies. Following these five suggestions can help your organization prevent data integrity failures and strengthen CGMP compliance.

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    6 Essential Capabilities of a Complete eDHR System

    While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes.

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  • 2022-bl-gxp-lifeline-biopharma-outsourcing-trends_132x132

    3 Biopharma Contracting Manufacturing Trends You Must Know

    Biopharma is rapidly becoming the most dynamic sector in the life sciences. But explosive growth brings new challenges in an industry dependent on contract manufacturing. Find out which market-changing trends you need to be aware of and what the future holds for biopharma contract manufacturers and their clients.

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  • 2022-bl-gxp-lifeline-quality-by-design_132x132

    5 Key Elements of Quality by Design in Pharma

    End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.

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  • 2022-bl-gxp-lifeline-writing-sop_132x132

    Simplified Guide to Writing Superior QMS SOPs

    Standard operating procedures (SOPs) are integral to successful quality management. However, they are not always the easiest to write or update. Learn how to improve compliance by building better procedural documents.

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  • 2022-bl-gxp-lifeline-oqsie-2_132x132

    Turning Document Review Findings Into Actionable Insights

    Lack of visibility into quality operations can keep you from gleaning actionable information from data that’s already at your disposal. OQSIE’s Jaime Velez explains how document review templates can help your organization significantly improve performance and the quality of your products.

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  • 2022-bl-med-dev-root-cause-analysis_132x132

    Optimizing Root Cause Analysis In Medtech Manufacturing

    When a medical device fails to function as intended, it can potentially affect patient safety and brand reputation and even lead to a recall. With effective root cause analysis, organizations can more easily detect, resolve, and prevent problems.

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  • 2022-bl-data-integrity-strategy_132x132

    Ensure Compliance With a Proactive Data Integrity Plan

    There are numerous U.S. Food and Drug Administration (FDA) regulations surrounding data integrity. A good approach to maintaining data integrity compliance is to develop a practical data integrity plan for successful data management.

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  • 2022-bl-eu-uk-post-brexit-regs_132x132

    11 Key Quality Regulation Terms to Know Post-Brexit

    Know these 11 key terms to understand the distinct quality regulations currently in effect in the EU and U.K. post-Brexit.

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