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GxP Lifeline
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    Assess Your Digital Manufacturing Maturity

    MasterControl recently conducted a study on the level of digitization deployed in pharma and medtech manufacturing. Find out how your company compares with your industry peers in terms of digital maturity and how to stay competitive in today’s market.

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    How Digital Transformation Is Impacting Medical Device Quality and Continuous Improvement

    With the advent of electronic quality management systems, AI, and other modern tools, medical device manufacturers are now able to optimize their operations to ensure that all products meet the highest standards. In this blog post, iDE8’s David Howarth explores the ways in which digital transformation is impacting medical device quality and continuous improvement.

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    5 Steps to Pass Your ISO 9001 Audit

    Audits are never a fun experience, but you can greatly reduce the stress if you prepare beforehand. Passing your ISO 9001 audit is completely doable by following these steps.

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    Transitioning to Validation 4.0: A Roadmap for the Journey

    With innovative technologies accelerating the speed with which computer systems can be validated, the decision to shift gears into Validation 4.0 sounds like a no-brainer. So why do so many life sciences companies struggle to find a starting point for implementation? Sware founder and CEO Bryan Ennis offers a proven roadmap for modern computer system validation success.

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    Medical Device Trends: Recall Readiness

    When it comes to recalls, medical devices don’t have the best track record and tend to outnumber those in other regulated industries. While it’s preferable to avoid recalls altogether, medical device companies need to have procedures in place just in case. Recommendations from the FDA help companies implement recalls faster and more accurately.

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    Trends in Quality Management: 3 Paths to Patient Centricity in Pharma

    It can be difficult to articulate what patient centricity means for pharma, let alone the benefits. Read this post to gain a clearer understanding of this relatively new approach to quality management, where it originates from, and practical ways to align your quality management system (QMS) with patient-centric principles.

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    Why Electronic Manufacturing Logbooks Are Better Than Paper

    Paperless automation makes the mundane tasks of our daily lives easier. It can be even more powerful when used on the shop floor. Replacing paper logbooks with electronic logbook software can bring not only greater efficiency for manufacturers, but also bring them closer to complete digital maturity.

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    4 Digital Transformation Gaps in Pharma and Medtech Manufacturing

    At MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organization can learn from the experience of others in overcoming production gaps.

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    4 Reasons Your Medical Device Startup is Ready for an eQMS

    Medtech startups face countless obstacles in their quest to achieve compliance and get products to market. While most recognize that modern technologies will enable them to reach their goals faster, it can be difficult to know when the time is right to invest in new solutions. Read on to learn four good reasons why a medical device startup should implement an electronic quality management system (eQMS) sooner rather than later.

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    How Regulatory Compliance Software Can Support the ISO 13485 Standard

    With the anticipated harmonization between the ISO 13485 standard and the U.S. Food and Drug Administration Quality System regulation (21 CFR Part 820) coming closer to fruition, it’s time for medical device designers and manufacturers to ask themselves a few questions, not the least of which being, “Am I ready?” and “What does it mean for me?” Another great one is this: “Is there a software solution that can make this easier?”

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    5 Steps to a Better Supplier Quality Audit

    Discover five often overlooked steps that can make your next supplier quality audit a more productive experience. Gain the major benefit of superior visibility into supplier performance and keep your supply chain moving.

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    Organizational Change Management Principles: Precede Action With Mindful Assessment

    Navigating and adapting to constant change requires more than a checklist mentality. Dr. Nancie Celini, president of Think OCM, explains why change management assessments must include mindful considerations and offers examples of the types of assessments that are ripe for a mindful approach.

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    Unlocking the Power of Your Manufacturing Execution System

    To stay current with trends and gain a competitive edge in the life sciences market, manufacturing organizations collect a lot of data from various sources. For this level of data gathering, companies not only need more storage capacity, but they also need data storage technology that allows for rapid search and retrieval. Find out why industry leaders employ a data lake to store and manage large volumes of data.

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    Risk-Based Supplier Management for Scaling Evaluation, Selection, and Control

    Regulators expect life sciences companies to take a risk-based approach to supplier management. But with so much supplier information to handle, how does an organization know which risks have been properly evaluated and controlled? QRx Partners’ Steve Gompertz examines the three critical phases of supplier management and explains how modern digital tools can streamline it.

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    Medical Device Trends: Medical Device Cybersecurity Guidance

    Connectivity offers many potential benefits to medical devices. Unfortunately, that connectivity also presents risks. That’s why regulators are coming out with cybersecurity guidance documents for medical device manufacturers.

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    8 Ways EBR Software Boosts Efficiency in Pharma Manufacturing

    In modern pharma manufacturing, the traditional, paper-based approach to managing production records and other essential documentation is too time-consuming and prone to errors to be effective. Find out eight ways electronic batch record (EBR) software can supercharge your operational efficiency.

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    Pharma Quality Management Trends: Adopting Intelligent Solutions

    If you haven’t already explored the benefits and necessities of artificial intelligence (AI) technology in pharmaceutical quality management, this is for you. The 2023 pharmaceutical industry trends show that applications of AI are increasing rapidly – and not a moment too soon. Unprecedented rates of vaccine development at the peak of the COVID crisis made the case for the value of life-sustaining AI technology. Are you there yet?

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    Digital Quality Management Is Hard - Here’s How To Do It Right

    Digitizing is a difficult process that involves every department in an organization. At MasterControl, we conducted original research on where the life sciences industry stands in its QMS digitization efforts and how we can help you make progress on your journey and overcome these difficulties.

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    Using the New Recommended Risk-Based Approach to Computer Software Validation

    Regulatory agencies encourage companies to take a risk-based approach to validating their software systems. To help companies achieve that goal, CloudWorks4All’s Ross Stoval examines the steps involved in implementing a new, risk-based validation methodology. Read on to learn how risk-based validation practices help companies in the life sciences save time and effort while making it much easier to adopt cloud-based systems like modern electronic quality management systems.

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    MDSAP Opens More Compliance Opportunities for Med Device Manufacturers

    Advanced technology has moved medical device innovation into the fast lane. It stands to reason that global regulatory agencies would step up to help keep the momentum going — and they have. In 2012, the International Medical Device Regulators Forum (IMDRF) rolled out the Medical Device Single Audit Program (MDSAP). This post details how the program works and how it continues to evolve.

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