May 5, 2021
By Cameron Loper, Digital Health Leader, MPR Associates
As Artificial Intelligence/Machine Learning (AI/ML) gain momentum, particularly in software as medical device (SaMD), a regulatory framework is being put in place by the U.S. Food and Drug Administration (FDA). In the first part of a two-part series, the benefits of AI/ML are discussed along with the numerous considerations that need to be taken into account by regulatory bodies.
May 4, 2021
By Sarah Beale, Staff Writer, MasterControl
Using the Force to make decisions in Star Wars works well. Tragically, since most of us don’t have that ability in the real world, we’d probably be better served if we listened to C-3PO more. While we’re short on protocol droids, we do have the tools to let you make decisions using advanced analytics and artificial intelligence (AI). And the odds of those paying off are considerably better than navigating an asteroid field.
May 3, 2021
By Andy Myslicki, Managing Director, Integrated Project Management Company
If you prepare for and manage compliance crises with disciplined leadership and formal processes, you can minimize disruption and damage. In fact, your processes, communication, and adaptability can get stronger from the experience.
April 29, 2021
By David Butcher, Staff Writer, MasterControl
For professionals in the business of quality, inspiration can be found in all sorts of ways, from studying other industries to browsing the patent office or even taking a different route to work. A simple but often motivating approach is to look to words of wisdom from experts in their fields. Here are five insightful quotations, from a variety of fields, that carry quite a bit of truth for quality professionals.
April 27, 2021
By Sarah Beale, Staff Writer, MasterControl
Before the Food, Drug, and Cosmetic Act of 1938, shopping could be hazardous to your health. The market was flooded with deceptive and dangerous products. The confidence we have today in food, drugs, medical devices, and cosmetics is largely due to the FD&C Act and the amendments that followed.
April 23, 2021
By David Butcher, Staff Writer, MasterControl
Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.
April 22, 2021
By Sara Bresee, Managing Director of APAC, MasterControl
At MasterControl, we are broadening our gaze to the Asia-Pacific (APAC) region. Managing Director of APAC, Sara Bresee, weighs in on why modern manufacturing solutions are critical to APAC and around the globe. A digital system is what’s needed to be adaptable, meet regulatory requirements, and deliver the high level of quality your customers deserve.
April 21, 2021
By David Jensen, Staff Writer, MasterControl
Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.
April 20, 2021
By Jean Boudaud, Device Consulting Manager and Senior Consultant, Brandwood CKC, and Brandwood CKC
As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.
April 15, 2021
By James Jardine, Staff Writer, MasterControl
Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.
April 9, 2021
By Nancie E. Celini, DrPH, Organizational Change Management Consultant
To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.
April 8, 2021
By Sarah Beale, Staff Writer, MasterControl
Sequence Senior Consultant Peter McGrath weighs in on the struggles of traditional computer system validation (CSV), and how they can be solved with a risk-based approach. Months of time are spent on traditional CSV to the process, which produces piles of documentation. It doesn't have to be that way.
April 6, 2021
By James Jardine, Staff Writer, MasterControl
If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.
April 1, 2021
By David Butcher, Staff Writer, MasterControl
In 2020, the COVID-19 pandemic brought to light the importance and acceleration of digitization. As precision medicine organizations continue reviewing and adjusting processes beyond the COVID-19 pandemic, there are some practical applications to consider in their efforts to embrace a modern approach to technology.
March 30, 2021
By Dale Thompson, Staff Writer, MasterControl
In the growing field of personalized medicine, there are significant opportunities for contract manufacturers, and the challenge to keep up with demand can be met by adopting the right technology.
March 26, 2021
By Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting, Inc.
The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product approval and audit schedules is dependent on maintaining a robust compliance roadmap, which includes sponsoring GxP audits.
March 24, 2021
By David Butcher, Staff Writer, MasterControl
Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.
March 22, 2021
By David Jensen, Staff Writer, MasterControl
Artificial intelligence (AI) technology has become pivotal in mainstream health care. The influx of big tech firms collaborating with incumbent life sciences companies to develop AI-based medical devices indicates that this trend will continue at a rapid pace.
March 19, 2021
By Michelle Sceppa, Principal, MSceppa Consulting
Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.
March 18, 2021
By Dirk Stynen, Ph. D., President and Principal Consultant, Qarad BV
Electronic distribution of instructions for use (eIFU) are becoming widely used among medical device manufacturers. Due to the increasing popularity, it is critical to understand eIFU within the context of regulations, particularly Europe’s new medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
