GxP Lifeline
  • 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

    Ultimate Guide Examines Digitization in Medtech Manufacturing

    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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  • 2022-bl-cmo-industry-brief_132x132

    Digital Transformation in Contract Manufacturing Industry Trends

    Depending on the degree of paper processes still being used by CMOs and CDMOs, their range of motion, or flexibility, to change with current market demands will be limited. We can look to an ancient paper application that has begun to utilize technology and discover the scope of transformation that becomes possible in life sciences manufacturing by eliminating every sheet of paper.

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  • 2022-bl-drug-gmp-warning_132x132

    The No. 1 Most Common Problem in FDA GMP Inspections

    Year over year, the biggest issue for pharma companies remains the same. Data from the U.S. Food and Drug Administration (FDA) shows that warning letters and Form 483s are most commonly issued for the same reason.

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  • 2022-bl-gxp-lifeline-oqsie_132x132

    Stop Throwing Away Valuable Data From Quality Management System Document Reviews and Start Using It

    Life sciences companies can leverage their current processes to start extracting meaningful data from their quality management systems, but many are missing the opportunity. OQSIE’s Jaime Velez explains how improvements to document review processes can make this happen, and how it is feasible in the near term for companies to make better data-driven decisions and improve the overall quality of their products.

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  • 2022-bl-iso-13485_132x132

    ISO 13485 Requirements: FAQ About the Top Medical Device Quality Management Standard

    Compliance with ISO 13485 requirements is evidence that a medtech manufacturer’s quality management system (QMS) and devices measure up to the highest standard of quality recognized worldwide. Just because the standard is widely acknowledged, however, doesn’t mean it’s well understood. Find answers to the most frequently asked questions about the medical device industry’s definitive QMS standard.

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  • 2022-bl-ocm-part-3_132x132

    OCM Exists to Mitigate Risk in eQMS Implementations

    The implementation of an electronic quality management system (eQMS) includes multiple, sometimes complicated stages. A sound organizational change management (OCM) is key to ensuring purposes and roles are clearly understood and that leaders are in lockstep strategically and operationally. The third part of this series on OCM implementation strategies explains how to create a blueprint for successful outcomes and prepare the way for your next project success.

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  • 2022-bl-gxp-lifeline-supplier-audit_132x132

    Improving Quality Through Supplier Audits

    Supplier audits are the cleverly disguised exams of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.

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  • MasterControl’s latest infographic on Pharma  Manufacturing Trends

    Your Pharma Manufacturing City of the Future

    The future of pharma manufacturing is here, and companies are racing to stay up to speed with the latest industry trends. A new interactive infographic tests your knowledge of pharma manufacturing trends and illustrates the optimal pharma manufacturing operation.

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  • Digitizing your medical device manufacturing shop floor helps with EU and US regulation compliance.

    EU MDR vs. U.S. QSR and the Role of Digitization

    There are more similarities than differences in the ways medical devices are regulated in the U.S. versus their regulation in Europe. But those subtle differences are critical to understand if you plan to market devices in both regions. See how EU and U.S. medical device regulations compare and learn how digitization streamlines compliance in both regions.

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  • Benefits of adopting a modern MES solution by pharma manufacturing companies, featured by MasterControl.

    A Modern Pharma MES Offers the Best of Old and New

    A manufacturing execution system (MES) solution should offer you the best pharma MES functionality in a simplified package to match your current and future manufacturing needs. Beyond that, it should also expand your visibility across critical pivot points throughout your manufacturing operation. Ultimately, it should support your organizational growth. This post discusses how a modern MES achieves these things.

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  • 3 steps to prepare Pharma CMOs and CDMOs meet supply continuity challenges.

    Maintaining Supply Continuity: 3 Ways to Ease Pharma CMO and CDMO Worries

    As we cope with the aftermath of COVID-19 in these uncertain times, it’s critical for pharma outsourcers to control the controllable aspects of supply continuity. These three practical steps will prepare pharma CMOs and CDMOs to handle the supply continuity challenges that will inevitably arise.

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  • MasterControl’s 6 Common Myths About Adopting a Manufacturing Execution System (MES) industry brief

    6 Common Barriers to Adopting a Traditional MES Solution

    For most production environments, the barriers to adopting a traditional manufacturing execution system (MES) have kept many organizations from digitizing and automating their manufacturing environment. However, new manufacturing technologies are providing smarter, faster, and more affordable paperless shop floor alternatives to legacy MES solutions.

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  • The alignment between the FDA’s ISO 13485 & 21 CFR Part 820 featured by quality management experts, MasterControl

    Bringing ISO 13485 to 21 CFR Part 820

    For years now, the FDA has observed that ISO 13485 and 21 CFR Part 820 have a great deal in common and largely accomplish the same level of quality assurance. Now the FDA’s working on harmonizing them.

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  • 3 Foundational Principles of Quality 4.0 featured by quality management experts, MasterControl

    3 Characteristics of Successful Quality 4.0 Initiatives

    Intelligent, connected technologies are transforming the way life sciences companies manufacture and ensure the quality of their products. To stay competitive, companies are taking advantage of advanced tools and new technology-enhanced approaches to quality management. Leveraging the new solutions and enhanced levels of connectivity now available requires that you first understand three foundational principles of fruitful Quality 4.0 initiatives.

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  • Medical Device DHF 21 CFR 820 Compliance

    Alleviating Headaches From 21 CFR 820 Design Control Compliance

    Compliant medical device design is governed by federal regulations along with competitive market needs. The essential aspects of a design control subsystem are outlined here, along with the most strenuous tasks related to design control, including design reviews. Converting from paper or hybrid quality management systems to an automated one can further reduce the challenges related to managing the Design History File (DHF) and help you to be ready for FDA inspections at any time.

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  • MasterControl’s ”Simplify your CAPA Process in 7 Steps” industry brief

    The CAPA Magnificent Seven

    Learn about seven ways to simplify your CAPA process by taking a closer look at the 1960s classic “The Magnificent Seven.”

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  • The relation between your OCM strategy and your eQMS success

    OCM and eQMS: Transformation or Conformance?

    The digitalization of quality processes can bring transformative change to an organization, but doing it right requires a sound strategy. Learn the four steps that form the foundation of a good organizational change management (OCM) plan.

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