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.
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.
June 27, 2019
By Dan O'Leary, President, Ombu Enterprises
Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.
June 25, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Quality 4.0 technologies are becoming ever more vital for prosperity. Learn why LNS Research and MasterControl say the experiences of early adopters have laid the groundwork for life sciences companies that are searching for successful industrial transformation (IX) strategies that combine mature technology with a business-first approach.
June 20, 2019
By David Jensen, Staff Writer, MasterControl
Researchers at the University of British Columbia (UBC) discovered that laboratory mice are not only biologically similar to humans, they also have similar aesthetic attributes. A recent study revealed that mice actually don’t like to sleep in sewage waste. Aside from affirming that mice might have some level of dignity and social grace, the study suggests that consistently exposing mice to “chronic averse stimuli” can negatively affect research data.
June 18, 2019
By Sarah Beale, Staff Writer, MasterControl
In 2019, more nutraceutical companies are nudging their way into the cosmetics space with the concept of “beauty from within.” With a focus on how nutrition affects physical appearance, nutricosmetics bridge the gap between nutrition and beauty and open new opportunities for supplement companies.
June 13, 2019
By Mike Rigert, Staff Writer, MasterControl
Global Positioning Systems (GPS) have largely replaced the way people navigate the world. In a similar fashion, manufacturers are increasingly turning to digital solutions to navigate production records and data management, resulting in fewer production errors, less waste and faster time to market – key advantages in a tightly contested marketplace.
June 6, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Why is it so difficult for life sciences companies to streamline their manufacturing operations and overcome recurring quality monitoring and analytics obstacles? Learn why LNS Research and MasterControl say the secret to efficiency can be found in the convergence of technology, manufacturing and Quality 4.0 — and why quality professionals should be at the forefront of modernization.
June 5, 2019
By Jared Evans, Lean Process Coach and Professional Instructor, MasterControl
Errors. Oversights. Accidents. Mishaps. Bloopers. Gaffes. Fails. Call them what you will, mistakes on the manufacturing floor are unavoidable. And while they usually carry a negative connotation, sometimes a mistake can make a lasting impact for the better.
May 30, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Can we maximize the benefits of automation without minimizing our humanity? Learn how to stay human in an automated world and explore real-world examples of life sciences professionals who enhance their capabilities by leveraging advanced automated tools.
The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.
Unsure about cloud validation? You’re not alone. Many life sciences and other regulated companies are unfamiliar with cloud-based quality management system (QMS) and wary about its validation. After all, their regulatory compliance is at stake.
May 22, 2019
By Grant Bennett, CEO, Brandwood Biomedical
The evolution of regulatory changes in the European Union with it’s Medical Device Regulation (MDR), the U.K.’s Brexit, and changes in Canada and elsewhere are creating a global ripple effect in the medical device industry. These hurdles may cause uncertainty for device makers, but through careful preparation and planning, medtech companies adjust their strategies and approaches during this transitionary period.
May 21, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Are our automated tools merely machines that complement and simplify our work, or will they ultimately make us obsolete? Learn why humans and their ability to solve problems and interpret information will always be the core component of any automation initiative.
