May 20, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.
May 19, 2021
By Dale Thompson, Staff Writer, MasterControl
All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.
May 13, 2021
By David Jensen, Staff Writer, MasterControl
More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.
May 12, 2021
By Cameron Loper, Digital Health Leader, MPR Associates
The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.
May 11, 2021
By David Butcher, Staff Writer, MasterControl
The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.
May 7, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.
May 6, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Early stage startups in the medical device/Medtech/in vitro diagnostic (IVD) world often struggle with when and how to implement a quality management system (QMS) into their operations.
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 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, GxP Lifeline Editor, 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 Leader, Think-OCM.org
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.
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, GxP Lifeline Editor, 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.
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