GxP Lifeline
  • 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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  • 2020-bl-author-brian-curran

    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-document-management-system_132x132

    Why You Need a Document Management System

    Document management systems have come a long way since the days of paper and filing cabinets. Learn how things have changed and how you can benefit from modernizing your document management system.

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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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  • 2022-bl-mx-med-device-trends_132x132

    Medical Device Manufacturing Trends, Pt. 3: Innovation Drives Regulatory Evolution

    Medtech manufacturing organizations face constant challenges around disruptive technologies, fast-growing amounts of data, and a changing regulatory landscape. As the use of advanced technology such as artificial intelligence (AI) and machine learning (ML) in medical devices in increases, so will new rules and regulations. To better navigate changing compliance requirements, manufacturers in the field of medical technology must leverage digitization in manufacturing to build quality assurance into production and improve data management across the product life cycle.

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  • 2022-bl-gxp-lifeline-elemental-machines_132x132

    Smart Technology Accelerates Biomanufacturing by Improving Reproducibility

    It’s impossible to compete in the high-pressure biotech world if your tools and internal processes aren’t up to the task. Learn how pairing advanced, purpose-built technologies can help streamline laboratory operations (LabOps) and accelerate drug discovery and development processes.

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

    8 Tips That Make Software Validation Less Painful

    Computer system validation (CSV) can be painful, but following these eight tips eliminates the pain and makes it possible to upgrade more often.

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  • 2022-bl-pharma-roundtable-recap_132x132

    Life Sciences Industry Experts Weigh In on Challenges Facing CMOs

    Contract Pharma assembled a panel of three seasoned life sciences industry manufacturing experts in a Q&A webinar to address the challenges contract manufacturing organizations (CMOs) have been facing in a pre- and post-COVID-19 pharma manufacturing environment. This post is a recap of that discussion.

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  • 2020-bl-process-verification_132x132

    FAQ: Clarifying Process Verification vs. Process Validation in Medtech

    To validate or to verify, that is the question medical device developers often wonder about their manufacturing processes. Learn the distinct differences between the two activities, why they’re both essential for compliance, and the circumstances in which each is required.

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  • 2022-bl-qx-metrics-that-matter_132x132

    Customers Share Their Quality Management System Metrics

    Our customers share the measurable improvements they’ve seen in their quality management system metrics since implementing MasterControl.

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  • 2022-bl-fda-predicate-rules_132x132

    The Role of FDA Predicate Rules in 21 CFR Part 11 Compliance

    Thanks to 21 CFR Part 11, the FDA recognizes that digitized records and signatures are just as valid as those maintained on paper. But that doesn’t mean Part 11 supersedes the requirements previously established in FDA predicate rules. Find out why your company’s compliance is dependent on understanding the applicable predicate rules.

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  • 2022-bl-fda_132x132

    10 Things to Know Before Writing an FDA 483 Response Letter

    Receiving an FDA 483 or warning letter requires prompt action from medical device manufacturers. But writing a response letter with remediation plan can seem daunting. These 10 things can start savvy manufacturers off on the right path.

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  • 2022-bl-medtech-manufacturing_132x132

    How to Digitize your MedTech Manufacturing Operations

    Even as digital transformation efforts accelerate in various areas of manufacturing, there remains an offline data gap created by device history records (DHRs) that rely on paper, spreadsheets, and other standalone systems. This gap slows production, quality review, and product release. What is missing in medtech manufacturing operations is the electronic DHR (eDHR) solution.

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  • 2022-bl-quality-audit-med-device_132x132

    Overcoming the Top 5 Pitfalls in Medical Device Quality System Auditing

    Audits provide crucial information to both FDA regulators and the medical device firms being audited. Depending on how proactive, consistent, and collaborative audit strategies are within medical device firms, investigations can become an asset to accelerate the development of safer, higher-quality products. Learn how using a medical device audit management software system can help your organization overcome common challenges while also providing benefits such as shorter audit times and less frequent visits from investigators.

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