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GxP Lifeline
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    ERP is NOT a Substitute for a QMS

    An enterprise resource planning (ERP) system is a powerful tool, but it can’t take the place of a purpose-built quality management system (QMS). CloudWorks4All’s Ross Stoval explains why a dual ERP/QMS backbone is integral to success in life sciences industries.

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    What Are the Measurable Benefits of Modern MES Software?

    While most manufacturers agree that digitization is essential to their success, most today can’t afford an expensive and time-consuming implementation of traditional manufacturing execution software with a slow return on investment. Implementation of a modern manufacturing execution system (MES) solution is fast and, once implemented, can deliver results quickly.

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    6 Solutions eQMS Software Provides Startups

    Most startups in the medical device industry understand that they could streamline operations with an electronic quality management system (eQMS), but just don’t know if the benefits are worth the cost. Cannon Quality Group highlights six solutions an eQMS provides for medtech startups.

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    4 Essential Components of an Audit Management System

    Dealing with remote compliance audits and inspections presented unique challenges. The new hybrid approach does have benefits, but also maintains some of the challenges from in-person and remote audits.

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    Creating a Lean Culture of Continuous Improvement in Manufacturing

    Every manufacturer aims for continuous improvement, but one of the biggest obstacles to achieving it is getting everyone on board with new processes or solutions that will make it possible. Find out how applying a hierarchy of needs approach to a 6S program makes it makes it more likely that your teams will adopt new lean manufacturing processes or continuous improvement software.

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    Masters Summit 2022 Recap: 3 Takeaways for Medical Device Manufacturers

    Masters Summit 2022 was a week of world-class education, insightful speakers, networking with industry peers, and fun. Find out which three themes repeatedly surfaced at this year’s event and what they mean for the future of medical device manufacturing.

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    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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    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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    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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    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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    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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    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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