March 19, 2020
By Brian Matye, CFO, Regulatory Compliance Associates Inc.
In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safe and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system that's well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.
March 17, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuing demand.
March 10, 2020
By Sarah Beale, Staff Writer, MasterControl
Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.
March 3, 2020
By David Jensen, Staff Writer, MasterControl
More companies in all industries are migrating to a cloud environment to benefit from the advanced computing power, abundant data storage, and ability to perform complex functions. The cloud provides significant value; however, security has often been a source of concern. This article dispels the five most common myths about cloud security.
February 27, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.
February 25, 2020
By Sarah Beale, Staff Writer, MasterControl
The idea behind personalized medicine has always been the goal for health care professionals, but it’s becoming truly achievable with recent advances in technology. For pharmaceutical and medical device companies in the market, here are three trends to help you through 2020.
February 18, 2020
By Ranjan Deshpande, Co-Founder, Luceats Consulting
With all the new digital technologies impacting the life sciences, don’t forget about robotic process automation (RPA). The potential of RPA to automate repetitive, data-intensive processes can increase efficiencies and quality while freeing up your staff for more meaningful functions and assignments.
February 13, 2020
By Sarah Beale, Staff Writer, MasterControl
It’s February, so stores are flooded with Valentine’s Day candy, flowers and greeting cards. None of these are for the quality-manufacturing relationship, but it still deserves some attention. If your quality and manufacturing departments have enough drama to give a rom-com a run for its money, it’s time to take the first step to bringing them together.
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.
