February 21, 2019
By Beth Pedersen, Staff Writer, MasterControl
Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.
February 20, 2019
By Beth Pedersen, Staff Writer, MasterControl
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.
February 19, 2019
By David Jensen, Staff Writer, MasterControl
Regulated companies seek every opportunity to get products on the global market faster, even pursuing simultaneous regulatory approval in two of the largest global markets – the United States (U.S.) and the European Union (EU). However, governing entities in both regions are embarking on changes that could disrupt this strategy.
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.
If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.
January 29, 2019
By David Butcher, Staff Writer, MasterControl
Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.
January 29, 2019
By James Jardine, GxP Lifeline Editor, MasterControl
Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.
January 23, 2019
By Bryant Headley, Customer Success Executive-Governments, MasterControl
Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.
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.
January 22, 2019
By David Butcher, Staff Writer, MasterControl
In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). The DHR is literally the history of the device, and manufacturers in the business of medical technology face common challenges when using a paper-based or partially electronic system.
January 17, 2019
By Sarah Beale, Staff Writer, MasterControl
Cannabis is complicated, with constantly changing legalities surrounding the industry. Companies wanting to enter this market might find the financial forecasts appealing, but they should also be aware of and prepared for the risks of this unique industry.
January 16, 2019
By Mike Rigert, Staff Writer, MasterControl
Sustainable manufacturing is no longer just a buzzword that looks good in your company’s annual report. Technology has advanced to the point where implementing sustainable manufacturing best practices can reduce waste and energy use while still delivering the quality, cost-effective products your customers want.
Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.
January 10, 2019
By Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting
In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.
January 9, 2019
By Sarah Beale, Staff Writer, MasterControl
Stagnation is the enemy of most businesses in most industries, making it hard to keep up – especially when it comes to technology. Managers starting to modernize their manufacturing floor should consider how to use that technology to make more products available more quickly with more advancements.
January 2, 2019
By Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner, and Tifany Desprez, Apsalys, a MasterControl Partner
The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.
January 2, 2019
By Alex Butler, Manager of Medical Device Solutions, MasterControl
This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.
December 20, 2018
By Beth Pedersen, Staff Writer, MasterControl
5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.
December 19, 2018
By Alex Butler, Manager of Medical Device Solutions, MasterControl
This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.
The concept of working robots has come a long way since Isaac Asimov’s science fiction stories circa 1940s. Today, robots work in Amazon warehouses, streamline the manufacturing process at Adidas, and serve amenities in Crowne Plaza hotels. How long will it take before we start seeing wanted ads for chief robotics officers (CRO) to manage a combined human and robotic workforce?
