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.
April 16, 2019
By David Butcher, Staff Writer, MasterControl
Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.
April 11, 2019
By Beth Pedersen, Staff Writer, MasterControl
A lot has changed since MasterControl’s beginning in 1993. As technology transforms the way we do business and quality becomes a true competitive advantage, MasterControl is evolving to better support the companies and industries we serve. We’re excited to announce that MasterControl will unveil a new look on May 1.
April 10, 2019
By David Jensen, Staff Writer, MasterControl
A new phase of the Industrial Revolution is ushering in new technologies and modernized operational strategies that no life sciences industry executive can afford to ignore. Regulated companies are highly encouraged to plan for future relevance and success by modernizing key processes and operations.
Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).
April 3, 2019
By Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO
In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.
April 2, 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.
