GxP Lifeline

 

  • Supply Chains Are High Risk For Hardware Hacking

    14 March, 2019 by David Jensen, Staff Writer, MasterControl

    The discovery of a mysterious microchip in servers used in U.S. government offices further blurred the line between fiction and reality. While network and software hacking dominates the cybersecurity spotlight, hardware often goes unnoticed and unprotected. Hence, companies are highly encouraged to give some much-needed attention to supply chain security.

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  • Data Integrity: Trends, Pitfalls, Solutions, and Why DI Is Still Making Headlines

    7 March, 2019 by Matt Brawner, Director of Sales Execution, Sequence

    In a modern, technological era with an ever-increasing amount of data and data systems, robust data integrity is crucially important, particularly for life science and other regulated industries. Learn the latest best practices to properly ensure that you company’s data is complete, consistent and accurate.

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  • 2019 Med Device Trends to Watch For: Human Factors Engineering

    6 March, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts

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  • Apply ISO 9001:2015’s HLS for Improved Document Control and Compliance

    5 March, 2019 by Mike Rigert, Staff Writer, MasterControl

    ISO 9001:2015 is currently a key focus for transition for many life science and other regulated industry organizations. The high level structure (HLS) format within the standard has explicit requirements and when implemented with a robust quality management system (QMS), can help companies improve their document control processes and compliance levels.

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  • R.I.P. Paper Processes

    28 February, 2019 by Heather McArthur, Sr. Director of Content Strategy, MasterControl

    For many clinical, quality and manufacturing professionals, a change in process or technologies can be hard. But now, more than ever in life sciences, there is a need to digitize and move off paper-based or hybrid solutions. Through small automation pilots, the pains of transformation get eased while opening up opportunities that unlock a wealth of data-driven insights.

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  • Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving into 2019

    26 February, 2019 by Grant Bennett, CEO, Brandwood Biomedical

    Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.

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  • EBR: Good for What Ails Your Batch Record Process

    21 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.

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  • Executive Perspective: Why Paperless Batch Records Make (Dollars and) Sense for Wellington Foods

    20 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Manufacturers across all industries continue to implement and expand their digital transformation strategies, and as a result, the presence of paper on the factory floor is in decline. But one critical production process is proving to be more dependent on paper than others – at least until now. With the help of an innovative new solution, contract manufacturer Wellington Foods is one of the first companies to fully digitize its batch record process, and it’s already reaping the benefits.

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  • Simultaneous US/EU Regulatory Approval: How Timing Could Be a Factor

    19 February, 2019 by David Jensen, Staff Writer, MasterControl

    Regulated companies seek every opportunity to get products on the global market faster, even pursuing simultaneous regulatory approval in two of the largest global markets – the United States (U.S.) and the European Union (EU). However, governing entities in both regions are embarking on changes that could disrupt this strategy.

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  • 2019 Med Device Trends to Watch For: Regulatory Changes

    14 February, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • Top 5 Nutraceutical Trends of 2019

    12 February, 2019 by Sarah Beale, Staff Writer, MasterControl

    Last year was a popular year for nutraceuticals and every indication is that this momentum will carry over into 2019. To prepare, we’ve compiled a list of the top five trends expected to shape the industry this year. Companies hoping to get ahead in 2019 need to embrace these trends in any way they can.

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  • 4 Tech Trends to Watch in Manufacturing Device History Records

    7 February, 2019 by David Butcher, Staff Writer, MasterControl

    As medical device manufacturers try to understand exactly how and where to use constantly evolving digital technologies to achieve better operational and quality results, they must keep a close eye on changes in automation and be agile to respond to these developments. Explore four trends the med device industry can expect in 2019 and beyond, particularly as they relate to manufacturers’ device history records (DHRs).

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  • 3 Trends Shaping the Pharma Industry in 2019

    6 February, 2019 by James Jardine, Staff Writer, MasterControl

    Pharmaceutical companies are continually hunting for innovations that might give them an advantage in an increasingly competitive and profitable market. This article takes a deep dive into the transformational effects that trends like AI, medical marijuana and cloud technologies are having on the pharma industry.

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  • Top 4 Manufacturing Trends Impacting the Batch Record Process in 2019

    5 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Technology is changing the way we do everything, and pharmaceutical manufacturing is no exception. A new MasterControl white paper discusses the tech trends pharma manufacturers should prepare for in 2019, particularly as they relate to the business-critical – and notoriously inefficient – batch record process.

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  • Regulatory Changes Top the List of 2019 Med Device Trends to Watch For

    31 January, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.

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  • 5 Ways to Digitally Transform Your Supply Chain

    29 January, 2019 by David Butcher, Staff Writer, MasterControl

    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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  • Recall Blunders: How to Avoid Them and How to Recover

    29 January, 2019 by James Jardine, Staff Writer, MasterControl

    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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  • Top 5 Shop Floor Safety Tips

    24 January, 2019 by James Jardine, Staff Writer, MasterControl

    Shop floor safety lapses lead to injuries, low morale, lawsuits, damaged reputations and reduced productivity. Learn the top five strategies for optimizing shop floor safety practices and establishing a culture of safety across a manufacturing enterprise.

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