March 8, 2022
By David Jensen, Staff Writer, MasterControl
In February 2020, the FDA granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus. The agency recently drafted two new guidances to make preparations for med device companies to return to normal regulatory operations.
March 3, 2022
By Grace Hopkins, Staff Writer, MasterControl
Starting as a small Bureau of Chemistry taking an interest in chemical preservatives, the FDA has grown into one of the largest agencies in the world and accounts for 20 cents of every consumer dollar spent. Although no one is keen on rules, as we look back on history it is clear why FDA regulations are crucial when it comes to consumer protection. Being able to keep up with their extensive list of standards is now only possible through digitization. Lucky for us, we are in an era of rapidly developing technology that will make it possible for manufacturers in all industries to gain quick FDA approval and be on market in record time.
March 1, 2022
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Medical device manufacturers need to manage risk from the beginning of product design and continue throughout the full product lifecycle - anything less jeopardizes product quality. Connected risk analysis is essential because it gives you a holistic view of risks and their potential impact. Having this level of visibility requires a digital quality management system.
February 24, 2022
By David Jensen, Staff Writer, MasterControl
Many medical device manufacturing businesses are busily exploring ways to reduce the soaring costs of health care. Medical device remanufacturer Northeast Scientific is contributing to the effort by repurposing single-use devices (SUDs) to make them fit and safe to reuse.
February 15, 2022
By Sarah Beale, Staff Writer, MasterControl
To improve quality, life sciences companies need to bring that data together, use automated analytics tools, and use artificial intelligence (AI) to improve performance. There are three main ways we’re preparing to help you do that.
February 8, 2022
By Dale Thompson, Staff Writer, MasterControl
In addition to focusing on more resilient supply chains, the pharma industry needs to prioritize ways to reduce human error in manufacturing. Human errors cost time and money, but they are often preventable.
These seven concepts are critical to understanding the U.S. Food and Drug Administration’s guidance “Quality Systems Approach to the Pharmaceutical Current Good Manufacturing Practice Regulations.”
January 27, 2022
By Dale Thompson, Staff Writer, MasterControl
Pharmaceutical companies need to partner with contract manufacturers capable of maintaining impeccable product quality. Follow these three tips to find a CMO in the pharma industry that can meet and exceed expectations.
January 25, 2022
By Sarah Beale, Staff Writer, MasterControl
It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.
January 20, 2022
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
No pharma company wants to fail an inspection, and yet it’s common for these five mistakes to interfere with compliance efforts. Industry expert Nicole Cannon offers tips on how to avoid them along with insight into how digitization can be part of the solution. Follow her advice to get safe, effective products to market quickly.
January 18, 2022
By David Butcher, Staff Writer, MasterControl
While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency.
To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.
January 11, 2022
By Edwin Chung, Vice President of Service Delivery, SPK and Associates
A medical device manufacturer was working across two disparate systems. The result? Mistakes made their way into the manufacturing process, which resulted in lengthy review times, and delayed speed to market. The solution was digitization, and it immediately saved them $42,000 per year.
January 6, 2022
By David Jensen, Staff Writer, MasterControl
Given the high numbers of pharmaceutical recalls and shortages, along with the current supply chain issues, product manufacturers are making modernization a higher priority. This post examines the new pharmaceutical manufacturing trends in modernization.
December 16, 2021
By Sarah Beale, Staff Writer, MasterControl
Artificial intelligence (AI) in health care has enormous potential, but AI-enabled software as a medical device (SaMD) is charting new territory. Last year, regulators indicated some of their priorities for AI in SaMD and what regulations might look like in the future.
December 14, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
FDA and other regulators are increasingly cracking down on pharma companies’ data integrity lapses. Learn the fundamentals of maximizing data usage that will help keep your quality and compliance activities aligned with regulatory expectations.
December 9, 2021
By David Butcher, Staff Writer, MasterControl
As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead.
With manufacturers digitizing at a rapid rate, understanding the core of the European Union’s (EU) guidelines, Annex 11, and its approximate FDA counterpart, 21 CFR Part 11, is more critical than ever. They are central to understanding the conditions for life sciences manufacturers’ electronic data in the EU and the U.S., and while the guidance is similar in both countries, it’s important to understand the key differences.
Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action/preventive action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.
December 2, 2021
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Paul Andrea, Independent Consultant, MWA Consulting, Inc.
Whether your start up company makes pharmaceutical products, biologics, or medical devices, you all have one thing in common. You need to implement a robust digital quality management system (QMS) at the early phase of product development to comply with the ever changing and more stringent regulations throughout the product life cycle.
