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 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.
If this year’s Consumer Electronics Show (CES) is any indication of things to come, we can expect the role of medical devices in digital health to move onward and upward. The popular annual trade show attracted over 500 exhibitors of digital health products, including hundreds of medical devices.
May 7, 2019
By Mike Rigert, Staff Writer, MasterControl
Robots and humans in factories of the future may well work more synergistically. However, many manufacturers have yet to adopt the principles of Industry 4.0 for digitized data directly on the shop floor. Costly, time-consuming paper-based document control processes are holding your company back. Learn how to increase quality and efficiencies through Industry 4.0 and Quality 4.0 to achieve a truly 21st century manufacturing organization.
May 2, 2019
By Sarah Beale, Staff Writer, MasterControl
Recalls can seem like the end of the world, but new FDA guidance seeks to change that. With a focus on training, record keeping and procedures, the recommendations are most effective with the help of automation and digitization.
May 1, 2019
By Sara Bresee, Managing Director of APAC, MasterControl
Beginnings are important because they often give a first impression. Today is a landmark day for MasterControl as we introduce not just our new look and feel, but also a renewed commitment to customers and an integrated platform of enterprise solutions. Today changes everything because #QualityChangesEverything.
May 1, 2019
By Beth Pedersen, Staff Writer, MasterControl
Quality and compliance are not what they were 25 years ago, 10 years ago, or even five years ago. And neither is MasterControl. Today, we launch the new MasterControl brand.
April 30, 2019
By Jae D. Yoo, PhD, MBA, Chief Technology Officer, Aprecia Pharmaceuticals
Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.
April 30, 2019
By Frits Stulp, Managing Director, Iperion Life Sciences Consultancy
The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.
April 25, 2019
By Mike Rigert, Staff Writer, MasterControl
Revolutions often take just the smallest act to become a widespread movement for change. J. Sterling Morton kicked off a worldwide forestation revolution in 1872, aka, Arbor Day. And digital transformation is currently revolutionizing the way life sciences and manufacturing companies do business. Declare “War on Paper” by joining the call to arms to go paperless.
April 23, 2019
By Tressa Daniels, Senior Manager of User Experience Design and Human Factors Engineering, Becton Dickinson
Human factors engineering (HFE), also called usability engineering, in an essential part of user experience design and a major component in ensuring that human well-being and system performance are optimized. Learn why device manufacturers can best benefit from HFE processes when they are integrated into the existing product development phase.
