August 26, 2021
By James Jardine, Staff Writer, 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.
July 1, 2021
By James Jardine, Staff Writer, MasterControl
Quality assurance and quality control aren’t identical or interchangeable. Comparing the two functions to television’s most enduring police crime drama might help you explain their differences to your peers.
June 2, 2021
By Philippe Charbon, President, 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.
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.
February 12, 2021
By Rod Farrar Director, Paladin Risk Management Services
The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.
February 10, 2021
By Dale Thompson, Staff Writer, MasterControl
The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.
January 19, 2021
By Sarah Beale, Staff Writer, MasterControl
Artificial intelligence (AI) isn’t just a cool tech trend. At the rate it’s going, it’s shaping the future of quality in the life sciences. Which is why we’ve designed a new data analytics solution that gives users complete control over their data and uses AI to drive decision-making.
At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.
December 15, 2020
By 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.
December 9, 2020
By David Jensen, Staff Writer, MasterControl
With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.
November 9, 2020
By Sarah Beale, Staff Writer, MasterControl
On 30 July 2020, we celebrated the 17th anniversary of the completion of the Human Genome Project (HGP). It took scientists 13 years to map and sequence all human genes, a staggering feat of modern science.
November 5, 2020
By Sarah Beale, Staff Writer, MasterControl
For regulated companies, there’s a whole lot riding on training. If someone isn’t trained or is trained improperly, the life-saving products of life sciences companies can become life-ending products.
November 3, 2020
By James Jardine, Staff Writer, MasterControl
To keep pace with the technological and scientific advancements that continue to shake up the pharmaceutical industry, companies are increasingly finding it necessary to adapt their strategies, procedures and business practices.
MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.
August 27, 2020
By Grant Bennett, CEO, Brandwood Biomedical
Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.
August 20, 2020
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.
August 5, 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.
