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.
January 28, 2021
by Ralph Hess, Vice President, Navigator Business Solutions
Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.
December 15, 2020
By Richard Goeb, Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
February 6, 2020
by Sarah Beale, Staff Writer, MasterControl
Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Learn how both play into quality management and how an enterprise quality management system simplifies them.
April 16, 2019
by David Butcher, Staff Writer, MasterControl
Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.
January 23, 2019
by Sarah Beale, Staff Writer, MasterControl
When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.
September 27, 2018
by Tifany Desprez, Communication & Marketing Manager with MasterControl Partner Apsalys
Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.
July 31, 2018
by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
June 14, 2018
by Sarah Beale, Staff Writer, MasterControl
Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.
May 31, 2018
by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl
An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.
April 3, 2018
by Dave Jensen, Staff Writer, MasterControl
First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).
February 1, 2018
By Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl
It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.
Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.
December 26, 2017
by James Jardine, Staff Writer, MasterControl
See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.
February 19, 2015
David R. Butcher, Marketing Communications, MasterControl
An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.
Using ISO parlance, a management system is designed to achieve objectives. In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers. A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.
October 28, 2014
David R. Butcher, Marketing Communications, MasterControl
In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?
September 23, 2014
Ed Grounds, President Integrated Solution Providers Software, Inc.
Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.
December 11, 2012
Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.
When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.
