GxP Lifeline
  • 2022-bl-medical-device-change-control_132x132

    Keys to Managing Change Control Effectively in Medical Device Manufacturing

    Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.

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  • 2022-bl-data-integrity-strategy_132x132

    How to Avoid Warning Letters for Data Integrity Nonconformances

    According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.

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  • 2022-bl-logbooks_132x132

    Logbook Software: Another Triumph in Paperless Document Management

    Equipment management is an essential part of product manufacturing. Everything that happens with equipment must be logged, and all log entries must be complete, accurate, and legible. With paper-based logbooks, this process is cumbersome and time-consuming. See how digitized logbook software alleviates the headaches that come with logging equipment activities.

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  • 2022-bl-gxp-lifeline-validation-tips_132x132

    4 Key Takeaways From the FDA’s Software Validation Guidance

    After several years of delay, the U.S. Food and Drug Administration (FDA) issued its computer software assurance (CSA) guidance. Now that it’s out, here are some things from the guidance to keep in mind the next time a validation project comes up.

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  • 2022-bl-gxp-lifeline-supply-chain-management_132x132

    3 Ways to Enhance Flexibility in Pharma Contract Manufacturing Supply Chains

    If there’s one thing pharma contract manufacturers can count on, it’s the inevitability of supply chain disruptions. Yet even though a great deal of flexibility is required to be able to respond to destabilizing events appropriately, it can be difficult to foster. Learn about three initiatives pharma CMOs and CDMOs can undertake to elevate the flexibility of and visibility into their supply chains and streamline supplier management overall.

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  • 2022-bl-gxp-lifeline-mx-configurability_132x132

    Benefits of Configurability in Modern MES Solutions

    Rigid, hard-coded process configurations often make traditional manufacturing execution systems (MES) difficult to adapt and scale. The no-code configuration provided by modern MES solutions allows manufacturers to configure quickly and allows for the flexibility to adjust processes, material, and equipment changes for varying products.

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  • 2022-bl-quality-audit-tools_132x132

    5 Effective Quality Audit Tools and Tips

    Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.

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  • 2022-bl-capa-metrics_132x132

    3 Ways to Improve CAPA Metrics

    Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.

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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 & 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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  • 2022-bl-cqg_132x132

    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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  • 2022-bl-qms-documentation_132x132

    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-enterprise-qms-software_132x132

    6 Best Practices for Enterprise Quality Management Solutions Implementation

    Contemplating implementing an enterprise quality management solution? Where to begin? This is no small undertaking, but it’s more than possible. Here are six proven best practices that MasterControl has pulled from thousands of successful implementation projects. You can use them as your guide. They include directions on organizing your objectives and your team, assessing risks, allocating resources, and critical communication strategies. Read on to see how these practical foundations will support your project through to completion.

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