• Thriving in a Digital Era, Part 2

    2 April, 2019 by David Jensen, Staff Writer, MasterControl

    Part 2 of the “Thriving in a Digital Era” article series takes a deep dive into how companies are strategically mapping out their future by leveraging modernized technologies and moving their critical business functions to the cloud.

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  • Bill of Materials Can Help Relieve Pain Points in Device Design Approval

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

    Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.

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  • Thriving in a Digital Era, Part 1

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

    Another phase of the industrial revolution — dubbed Industry 4.0 — is underway and gaining momentum. While the previous phases of the industrial revolution have been about adopting new technologies, Industry 4.0 is about redefining the organizational culture.

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  • How Blockchain May Affect Manufacturing

    26 March, 2019 by David Butcher, Staff Writer, MasterControl

    Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.

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  • How Moving to the Cloud Has Become Easier For Life Sciences Companies

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

    Cloud technology has reached a level of maturity where many regulated organizations are discovering that operating in the cloud is becoming essential, rather than an option. A new white paper discusses the benefits of moving to the cloud and how cloud service providers are making the migration process smoother and faster.

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  • Cheers to Craft Beer: A Tradition of Quality, Innovation and Community

    19 March, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Beer has long been a staple beverage in human society. Beyond its taste and nutritional characteristics, beer’s greatest virtue is its ability to create shared social experiences for people the world over. To quench their thirst for innovative flavors, local goods and the highest possible quality, today’s beer drinkers are turning to craft beer in droves.

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  • 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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  • Building an Effective Global Regulatory Strategy for Medical Devices

    13 March, 2019 by Linda Chatwin, Esq., RAC, Sr. Customer Solutions Consultant, Health Sciences Division UL

    As new technologies evolve, the device requirements for medical device companies in various global markets has become more complex and nuanced. To be successful in key markets around the world, device makers need to study these regulatory environments and develop a strategy to more seamlessly and efficiently acquire regulatory approvals.

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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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  • 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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  • 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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  • 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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  • Millennials Are Set to Shake Up Manufacturing

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

    Millennials may be stereotypically known for ruining things, but they could actually be saving manufacturing. This industry is undergoing a digital transformation that requires employees who are very tech savvy – such as millennials.

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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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