February 11, 2020
By David Butcher, Staff Writer, MasterControl
In a new case study video, EpiBone, a Brooklyn-based regenerative medicine company developing living grafts for skeletal reconstruction, explains how it is leveraging MasterControl's QMS and manufacturing software to reduce errors and increase efficiency in the management of its quality processes and production records.
January 30, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Companies whose quality management practices are document dependent are neglecting the insights trapped in their quality data. Learn about the promise and peril of unstructured data and how connectivity can unlock your quality function’s potential.
January 28, 2020
By Mike Rigert, Staff Writer, MasterControl
Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.
January 23, 2020
By Sue Spenser, Head of IVD and Principal Consultant, Qserve
The European Union’s In Vitro Device Regulation (IVDR) is replacing the In Vitro Device Directive (IVDD) on May 20, 2022, and there’s not a moment to spare in preparing for the new regulation. An in vitro diagnostic (IVD) expert with QServe lays out the most important requirements of IVDR that IVD manufacturers will need to begin planning for to recertify their devices.
January 21, 2020
By David Jensen, Staff Writer, MasterControl
For decades, the science fiction world has often included some version of artificial intelligence (AI). While audiences were watching AI entities and robots come alive on the big screen, technology scientists were busily researching and developing the real thing. This article discusses the concept of augmented intelligence and how it underscores the importance of human creativity and innovation in the context of advanced technology and artificial intelligence.
January 16, 2020
By Mike Rigert, Staff Writer, MasterControl
With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.
January 14, 2020
By Sarah Beale, Staff Writer, MasterControl
The new year is the typical time when we set resolutions to improve ourselves. Since companies are in need of improvement too, make a resolution to digitize your business. If you’re not sure how to start, we’ve got some ideas.
January 7, 2020
By J. Lawrence Stevens, RAC and principal consultant, One Way Consultants
The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.
December 31, 2019
By Christine Park, Founder and Consultant, Christine Park & Associates
Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.
December 19, 2019
By Beth Pedersen, Staff Writer, MasterControl
As technology and the marketplace undergo drastic change, it seems the ROI of enterprise manufacturing software systems has reached a tipping point. But with the help of new additive technologies and small automation efforts, core systems will continue to play a significant – albeit evolving – role in modern manufacturing.
December 17, 2019
By Sarah Beale, Staff Writer, MasterControl
It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.
December 12, 2019
By David Jensen, Staff Writer, MasterControl
Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.
December 11, 2019
By Mike Rigert, Staff Writer, MasterControl
A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.
December 10, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Cochlear’s cochlear implants are more than just groundbreaking medical devices — they’re a life-redefining means through which people with hearing loss to connect with the world. Learn how the company is bringing innovative products to more people in need by accelerating quality and compliance processes with robust digital solutions.
December 5, 2019
By Mike Rigert, Staff Writer, MasterControl
The further we go into the 21st century the more it becomes apparent that the future of manufacturing will be digital. Find out how digital supply networks and smart factories will form the backbone of the digital transformation and what role quality and an automated quality management system (QMS) will play as manufacturing enters the Fourth Industrial Revolution.
December 4, 2019
By Sarah Beale, Staff Writer, MasterControl
The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.
November 21, 2019
By Mike Rigert, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.
November 12, 2019
By Sarah Beale, Staff Writer, MasterControl
In October, the 25th Annual Validation Week was held in Las Vegas, Nevada. The presenters included current and former employees of the U.S. Food and Drug Administration (FDA), and validation experts from the life sciences. This article explores the prevalent themes from the conference and how they will change validation.
November 7, 2019
By Sarah Beale, Staff Writer, MasterControl
Technology’s getting more advanced and our validation practices are finally starting to catch up. During the 2019 Masters Summit, Validation Product Manager Erin Wright gave us a glimpse at what’s in the future. Read about the next big trends in validation, including the U.S. Food and Drug Administration’s (FDA) stance.
November 5, 2019
By Mike Rigert, Staff Writer, MasterControl
The digital transformation and the ensuing War on Paper are changing the way life sciences manufacturers view speedy yet compliant production and the way they calculate ROI. Increasingly, companies are foregoing manual data systems in favor of a more efficient and cost-effective digital solution.
