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GxP Lifeline
  • 2020-bl-thumb-spc-sqc

    SPC vs SQC: The Strategic Difference

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • MasterControl Logo

    Our Expert Weighs in on Platforms, Data and AI

    MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.

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  • MasterControl Logo

    Four 2019 Manufacturing Batch Record Trends Holding Up in 2020

    Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.

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  • 2020-bl-thumb-3-main-barriers-to-connected-quality

    3 Main Barriers to Connected Quality and How to Overcome Them

    Shrinking margins, intensifying competition and rapidly increasing product personalization and customization are complicating new product introduction pipelines in the life sciences. Leveraging the data connectivity capabilities of platforms is the key to overcoming these and other obstructions to a connected quality life cycle.

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  • 2019-bl-thumb-prepare-for-the-future-of-quality-now

    5 Ways to Prepare for the Future of Quality Now

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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  • 2019-bl-thumb-a-love-affair-with-quality-mx

    When Sparks Fly: Conflict Resolution for Quality and Manufacturing

    Sparks have long flown between quality and manufacturing, and the adversarial nature of their relationship seems to be an accepted reality. But rarely does the discussion move beyond simply recognizing that a conflict exists. What is the cause of the divide? How can it be bridged? And what do companies stand to gain by doing so?

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  • 2019-bl-thumb-how-a-qms-can-improve-quality-control

    What Is a Quality Control System and How Can an EQMS Give it a Boost?

    Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.

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  • 2018-bl-thumb-creating-an-audit-ready-qms

    Building an Audit-Ready QMS

    Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.

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  • 2018-bl-thumb-fmea-without-tears

    FMEA Without Tears: A Prescription to Reduce Pain and Confusion

    Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

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  • 2018-bl-thumb-top-5-nutraceutical-trends-qualifying-suppliers

    Using an Integrated QMS to Qualify Your Suppliers

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    Regulatory Barriers to Innovation for Startups

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • 2020-bl-connectivity-02_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • 2020-bl-connectivity-03_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 1

    The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.

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  • 2018-bl-thumb-how-minimize-protocol-deviations

    How to Minimize Protocol Deviations

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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  • 2018-bl-thumb-compliant-analysis

    Complaint Analysis: Don’t Forget the Work You’ve Already Done

    This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.

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  • 2018-bl-thumb-eus-gdpr

    GDPR Deadline Approaches: What Is Expected for Compliance?

    First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

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  • MasterControl Logo

    What, No Installation Records?

    Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.

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  • 2022-bl-gxp-lifeline-quality-4.0-oqsie_1200x628

    February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • MasterControl Logo

    January Tip: How to Choose and Use External Consultants

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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  • 2018-bl-thumb-ensuring-quality-med-device

    Ensuring Quality In Medical Device Trials

    Manufacturers have used a quality systems approach to ensure consistency within their processes for years, but the FDA is now encouraging clinical researchers to take a similar approach to medical device trials.

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