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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.
A new phase of the Industrial Revolution is ushering in new technologies and modernized operational strategies that no life sciences industry executive can afford to ignore. Regulated companies are highly encouraged to plan for future relevance and success by modernizing key processes and operations.
Manufacturers across all industries continue to implement and expand their digital transformation strategies, and as a result, the presence of paper on the factory floor is in decline. But one critical production process is proving to be more dependent on paper than others – at least until now. With the help of an innovative new solution, contract manufacturer Wellington Foods is one of the first companies to fully digitize its batch record process, and it’s already reaping the benefits.
Technology is changing the way we do everything, and pharmaceutical manufacturing is no exception. A new MasterControl white paper discusses the tech trends pharma manufacturers should prepare for in 2019, particularly as they relate to the business-critical – and notoriously inefficient – batch record process.
Champagne has long been a staple of holidays and momentous occasions. The bubbly beverage is also deeply rooted in culture and tradition. To coincide with the mirth and merriment of the holiday season, this article discusses the rich history of Champagne and how it has become synonymous with quality.
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.
Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.
Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.
Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.
Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.
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.
Many consumers don't get enough fiber, leading to health problems that are especially prevalent as people get older. Fiber supplements can help fill the gap, and now the FDA has expanded its definition of dietary fiber to include eight more sources.
Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.
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.
Quality assurance professionals are experts when it comes to talking about time management. But how to they fare in practice? Find out in this month's Quality Manager Tip by Walt Murray.
An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.
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.
Data management technologies continue to evolve and improve the processes for collecting, storing and analyzing data. However, new technology rarely avoids growing pains. One dilemma regulated companies face with technology updates is maintaining data integrity. Regulatory guidelines for data integrity insist that all data and metadata remain intact and unaltered. This is a tall order when companies need to perform a large-scale data migration each time they update their data storage infrastructure. A good approach to effectively manage data and remain compliant with data integrity requirements is to develop a practical data management strategy around data storage and migration.
Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."
With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.
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