October 17, 2019
By Vergel Manalo, Team Lead – Medicines and Senior Consultant, Brandwood CKC
Global regulatory requirements are seemingly in a state of constant flux. Thus, it can be confusing for life sciences companies to grasp the exact nature of each region’s regulatory agency policies. This article breaks down some of the regulatory basics and more nuanced portions of Australia’s Therapeutic Goods Administration (TGA).
October 8, 2019
By David Jensen, Staff Writer, MasterControl
Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.
October 1, 2019
By Dave Edwards, Executive Vice President, MasterControl
Life sciences manufacturers are grappling for every advantage they can get in saturated, highly competitive markets. The implementation of lean programs is one way to achieve greater efficiencies. But in order to fully realize the benefits of lean, manufacturers need to replace manual paper-based data systems with a digital production records solution.
September 26, 2019
By Beth Pedersen, Staff Writer, MasterControl
As the manufacturing floor becomes more digitized and automated, a curious thing is happening. Instead of replacing human workers, advanced tech is highlighting the importance of people as decision-makers and innovators. The lesson that many companies are now learning firsthand is that if digital transformation is to fully deliver on its potential, it must support and adapt to human processes and preferences, not the other way around.
September 24, 2019
By David Jensen, Staff Writer, MasterControl
Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.
September 19, 2019
By Mike Rigert, Staff Writer, MasterControl
The medical device industry is changing at a pace that most in the industry are struggling to keep up with. And nowhere is that more evident than in medtech’s clinical research and trials space. Glean some of the hottest new clinical trends as we move into Q3 and Q4 of 2019.
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 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 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 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.
