September 17, 2019
By Mike Rigert, Staff Writer, MasterControl
Europe’s new regulation for medical devices, the Medical Device Regulation (MDR) takes effect May 26, 2019. Due to confusion regarding the regulation’s requirements and a lack of Notified Bodies to recertify medical devices under the new law, greater clarity is needed. Learn the latest on the developing situation and what med dev companies can do to prepare to recertify their devices.
September 10, 2019
By Bryant Headley, Customer Success Executive-Governments, MasterControl
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 providing you with both greater soft and hard ROI.
September 5, 2019
By David Jensen, Staff Writer, MasterControl
WD-40 has been silencing squeaks and vanquishing rust and corrosion all over the world since 1953. This success story can be attributed to the product’s secret formula. To the company’s employees, the product's legacy is largely due to effective quality management. In a new video, several WD-40 Company team members tell how quality is the company’s number one priority.
August 29, 2019
by Andrea Pilon Artman, Founder, SpectRA Compliance
Medical device manufacturers are often confused about the regulatory requirements when expanding their product line from Class II devices to also include Class III devices. Learn what is and what is not required of your quality management system (QMS) and premarket approval application for Class III devices.
August 22, 2019
By David Butcher, Staff Writer, MasterControl,Pete Raghubans, Quality Assurance Manager, EpiBone, and Julia Porrino, Quality Assurance Specialist, EpiBone
In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.
August 21, 2019
By Jenny Lin, Consultant, Brandwood CKC
Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.
August 20, 2019
By David Jensen, Staff Writer, MasterControl
Despite some initial hesitancy with advancing technology, health care-related industries are making significant strides in innovation and modernization. The emergence of digitized mobile and wearable medical devices, medical apps and telemedicine technology is evidence that life sciences companies are becoming leading drivers of innovation.
August 15, 2019
By James Jardine, GxP Lifeline Editor, 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.
August 13, 2019
By Camille Bouscaud, Quality Engineer Consultant, Apsalys
The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.
August 8, 2019
By Sarah Beale, Staff Writer, MasterControl
When fighting the War on Paper, it helps to turn to the foremost expert on war. Sun Tzu offers words of wisdom for starting to digitize, getting support from your organization, and how to build upon your successes. Here are five quotes from The Art of War to inspire you to take the battle to your office and permanently get rid of paper.
August 6, 2019
By Sarah Beale, Staff Writer, MasterControl
Supplements aren’t just for people anymore. The pet supplement market has grown with the human supplement market and there’s every indication that it will continue to do so. Taking advantage of this trend involves producing better quality supplements, conducting clinical research, and embracing technology to improve production.
August 1, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Patient centricity, transformative technologies and the importance of high-quality and clinically meaningful data were the major themes at DIA Global 2019. Learn about the trends having the biggest impact on the evolving life sciences landscape.
July 25, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
By getting FDA approval for its wearable technology just two years after its founding, BraveHeart Wireless is proving that there has never been a better time for startups in the life sciences to embrace cloud technology. Learn how cloud-based solutions are accelerating BraveHeart’s successes.
July 23, 2019
By Sarah Beale, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) is looking to build on the Food Safety and Modernization Act (FSMA) to use digitization to improve food safety. This “New Era of Smarter Food Safety” introduces concepts that fully embrace technological innovation and encourage food companies to use digitization to avoid future problems while complying with FSMA.
July 18, 2019
By Beth Pedersen, Staff Writer, MasterControl
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?
July 16, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
In the manufacturing world, calculable metrics and reproducible outcomes are all that matter. Learn about the three main measurable benefits that manufacturers are realizing by replacing their paper-based processes and production record management practices with fully digitized systems.
July 11, 2019
By Sarah Beale, Staff Writer, MasterControl
As cannabis legalization spreads, cannabis companies need to ensure they can keep up with their competition and regulations. A quality management system (QMS) gives these businesses the tools they need to overcome their unique challenges.
July 9, 2019
By Ian Lucas, Partner and Director, SeerPharma
It’s essential for life sciences and other regulated companies to certify that their IT infrastructure is up to specifications through system validations and qualifications, not only for better compliance, but also to ensure the quality and integrity of their data and production documentation.
July 3, 2019
By Mike Rigert, Staff Writer, MasterControl
“The Big Lebowski,” starring the indefatigable Jeff Bridges, has attracted a cult following over the years. The 1998 film features some of the most quotable lines in film. And, surprise — they apply to the field of quality management.
July 2, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Cloud networks, once shunned in the life sciences, have become essential tools for pharmaceutical organizations that want to keep pace with modernized competitors and an increasingly streamlined world. Learn about 10 distinct advantages cloud technology provides to pharma companies.
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