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.
October 31, 2019
By Sarah Beale, Staff Writer, MasterControl
The War on Paper is being waged against paper-based systems and is won by digitizing. Recently, MasterControl partnered up with DocuSign on a webinar discussing the benefits of going digital. Read some of the highlights or watch the webinar recording if you missed it.
October 29, 2019
By David Butcher, Staff Writer, MasterControl
In a recent presentation at MD&M Minneapolis, Terrance Holbrook, director of product at MasterControl, and Robert DePalma, VP of regulatory affairs at Pyrexar Medical, explained how manufacturers that digitally connect their production record system with other data sources will quickly stand apart from competitors.
October 24, 2019
By Mike Rigert, Staff Writer, MasterControl
Medical device manufacturers globally are grappling to recertify their devices against the European Union’s new Medical Device Regulation (MDR), which takes affect May 26, 2020. To help manufacturers make sense of the MDR, a Q&A was conducted with two medtech subject matter experts who tackle some of the most commonly asked questions about the MDR and how to approach it.
October 22, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Science and art may seem to have few commonalities, but creative achievements like origami models and musical compositions are closely linked with beneficial scientific applications, according to the keynote addresses at the 2019 Masters Summit. Learn about the insights that origami innovator Dr. Robert Lang and independent filmmaker Irene Taylor Brodsky have discovered in the space where art and technology intersect.
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 3, 2019
By Sarah Beale, Staff Writer, MasterControl
Plastic is the new GMO. It’s experiencing similar ostracization due to the large amounts of plastic produced each year that winds up in landfills and in the ocean. Moving away from a plastic dependency requires nutraceutical companies to be prepared with innovative ideas and a manufacturing process that is easily adaptable.
