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GxP Lifeline
  • 2019-bl-thumb-digitally-transform-the-supply-chain

    5 Ways to Digitally Transform Your Supply Chain

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

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  • 2019-bl-thumb-manufacturing-recall-blunders

    Recall Blunders: How to Avoid Them and How to Recover

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

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  • 2019-bl-thumb-costs-of-paper-hard-vs-soft-roi

    Costs of Paper: Hard vs. Soft ROI

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.

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  • 2019-bl-thumb-using-sherlock-holmes-to-pick-a-consultant

    Using Sherlock Holmes to Pick a Consultant

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • 2020-bl-manufacturing-excellence-04_132x132

    4 Common Pains in Managing Device History Records for Medical Device Manufacturing

    In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). The DHR is literally the history of the device, and manufacturers in the business of medical technology face common challenges when using a paper-based or partially electronic system.

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  • 2018-bl-thumb-manufacturing-and-cannabis-laws

    Rolling the Dice on Cannabis Manufacturing

    Cannabis is complicated, with constantly changing legalities surrounding the industry. Companies wanting to enter this market might find the financial forecasts appealing, but they should also be aware of and prepared for the risks of this unique industry.

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  • ukraine-mountain-landscapes-132

    How Sustainable Manufacturing Can Help the Environment and Your ROI

    Sustainable manufacturing is no longer just a buzzword that looks good in your company’s annual report. Technology has advanced to the point where implementing sustainable manufacturing best practices can reduce waste and energy use while still delivering the quality, cost-effective products your customers want.

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  • blue-operation-table-with-nurse-132

    4 Tips to Improve Your Medical Device Regulatory Submissions

    Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.

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  • white-empty-warehouse-132

    Call and Response: RFPs and Vendor Proposals

    In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.

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  • 2018-bl-thumb-modernizing-manufacturing-digital-trends-january

    Modernizing Manufacturing With Digital Trends

    Stagnation is the enemy of most businesses in most industries, making it hard to keep up – especially when it comes to technology. Managers starting to modernize their manufacturing floor should consider how to use that technology to make more products available more quickly with more advancements.

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  • warehouse-logististics-icons-132

    Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

    Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.

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  • smart-document-contract-132

    5 Keys to Helping Your Device Company Gain MDSAP Certification

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

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  • 2018-bl-thumb-modernizing

    Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

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  • 2018-bl-thumb-guiding-medical-device-through-mdsap-audit-process

    MDSAP: Guiding Your Company Through the Audit Process

    Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.

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  • 2018-bl-thumb-finding-success-with-6s

    Safety Is the Key to 6S

    5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.

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  • 2018-bl-thumb-modernizing

    Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2

    This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.

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  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-1

    Wanted: Chief Robotics Officers in Manufacturing

    The concept of working robots has come a long way since Isaac Asimov’s science fiction stories circa 1940s. Today, robots work in Amazon warehouses, streamline the manufacturing process at Adidas, and serve amenities in Crowne Plaza hotels. How long will it take before we start seeing wanted ads for chief robotics officers (CRO) to manage a combined human and robotic workforce?

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  • 2018-bl-thumb-modernizing

    Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 1

    This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.

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  • 2018-bl-thumb-santa-embraces-manufacturing-excellence

    Santa Embraces Manufacturing Excellence

    When you’ve got a hard deadline, efficiency is everything and no one knows this better than Santa. While he has the entire year to prepare for December 25th, he’s also preparing up until the last second to ensure he’s got everything ready for the big day. To pull this off, he needs a reliable digital production records solution.

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  • artificial-intelligence-132

    From Smart to Brilliant and Beyond: 3 Ways AI Is Changing Manufacturing

    Artificial intelligence (AI) offers unprecedented opportunities for productivity and economic growth in manufacturing and other key industries. Manufacturers are already leveraging AI on the factory floor in highly innovative ways and seeing measurable results.

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