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GxP Lifeline

Showing items tagged as Quality

  • 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-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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  • How digitized MES and QMS help medical device manufacturing companies produce products for gene and cell therapies.

    Quality and Manufacturing System Implications for Cell and Gene Therapy

    With the significant advances in gene and cell therapies, companies producing breakthrough products are facing obstacles ranging from challenges with development to transitioning to commercial manufacturing. Solutions can be found in digital manufacturing execution systems (MES) and quality management systems (QMS).

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  • Differences between Quality Assurance, Quality Control and Quality Management for Life Sciences Manufacturing.

    Quality Assurance, Quality Control, and Quality Management Systems: Clarifying Confusion

    There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.

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  • 2021-bl-iso-standards_132x132

    ISO Standards: Turning Hopes Into True Quality Objectives

    Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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  • 2021-bl-career-in-quality-management_132x132

    Pursuing a Career in Quality Q&A — Part 1

    The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.

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  • 2021-bl-coda-corp-quality-personnel_132x132

    Think Systems: Cause Quality

    With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.

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  • 2020-bl-2020-qa-vs-qc_132x132-main-thumb

    Get Quality Clarity: Your Guide to Understanding Quality’s Interactive Elements

    To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.

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  • 2021-bl-fda-eu-inspections_132x132

    FDA vs. EU Inspections: Similarities and Differences

    In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.

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  • 2021-bl-sue-marchant-plenary_132x132

    2021: The Year for Insights Into Quality Data

    The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.

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  • 2021-bl-global-regulatory-strategy-plan_132x132

    How to Create an Effective Global Regulatory Strategy and Plan

    An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • 2020-bl-cqg-quality-mgmt-trends_132x132

    Three Quality Management Trends to Watch in 2021

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • 2020-bl-coda-corp_132x132

    The Fundamentals of Immunization, Part 3

    Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.

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  • 2020-bl-5-w-of-quality-agreements_132x132

    Quality Agreements With Contract Manufacturing Organizations (CMOs)

    Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.

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  • 2020-bl-using-connected-quality_132x132

    Using Connected Quality to Track Down Problems

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • 2020-bl-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 2

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.

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  • MasterControl Logo

    How to Shift From Proactive to Predictive Quality Data Management

    The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.

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