March 12, 2021
By James Jardine, Staff Writer, MasterControl
To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.
Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.
February 2, 2021
By David Jensen, Staff Writer, Master Control
Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. This article explains how companies are emerging as leaders in their industries by implementing a data-driven approach to quality management.
January 28, 2021
By Cheryl Wagoner, Wagoner Consulting LLC
An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.
December 22, 2020
By Jason Clegg, Director of Marketing, MasterControl
It’s impossible to avoid occasional nonconforming products and materials. But what’s most important for manufacturers of regulated products is how nonconformances are managed. Learn how to handle nonconformance challenges, avoid warning letters and maintain alignment with FDA and ISO requirements.
November 13, 2020
By James Jardine, Staff Writer, MasterControl
Trend analysis in quality management is particularly useful for monitoring process changes that can yield substantial process improvements. Learn how advanced digital tools can supercharge your trend analysis capabilities by providing access to real-time, connected quality data.
September 4, 2020
By Jason Clegg, Director, Marketing Strategy
Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.
When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.
The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.
July 17, 2020
by Belinda Dowsett, Quality Assurance Manager and Consultant
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
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.
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.
February 14, 2019
by Cindy Fazzi, Staff Writer, MasterControl
For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.
November 13, 2018
by Kimberlee A. Washburn, Regulatory Affairs Author
Quality assurance and quality control functions in the manufacturing process may share some similarities but they’re actually quite different animals. Learn about the purpose of each and their relationship to each other in enabling life sciences and other regulated manufacturers to maintain a high level of quality and compliance for their products.
October 18, 2018
by Stephanie Christopher, Program Director, Medical Device Innovation Consortium
We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.
October 16, 2018
by David Jensen, Staff Writer, MasterControl
One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.
June 21, 2018
by Matthew M. Lowe, Executive Vice President of MasterControl
Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.
June 19, 2018
by Matthew M. Lowe, Executive Vice President, MasterControl
In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.
June 14, 2018
by Jonathan M. Lewis, Prinicipal, Advanced Biomedical Consulting
A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.
May 29, 2018
by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl
The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.
