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.
April 11, 2019
By Beth Pedersen, Staff Writer, MasterControl
A lot has changed since MasterControl’s beginning in 1993. As technology transforms the way we do business and quality becomes a true competitive advantage, MasterControl is evolving to better support the companies and industries we serve. We’re excited to announce that MasterControl will unveil a new look on May 1.
April 10, 2019
By David Jensen, Staff Writer, MasterControl
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.
Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).
April 3, 2019
By Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO
In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.
April 2, 2019
By David Jensen, Staff Writer, MasterControl
Part 2 of the “Thriving in a Digital Era” article series takes a deep dive into how companies are strategically mapping out their future by leveraging modernized technologies and moving their critical business functions to the cloud.
March 28, 2019
By Mike Rigert, Staff Writer, MasterControl
Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.
March 27, 2019
By David Jensen, Staff Writer, MasterControl
Another phase of the industrial revolution — dubbed Industry 4.0 — is underway and gaining momentum. While the previous phases of the industrial revolution have been about adopting new technologies, Industry 4.0 is about redefining the organizational culture.
March 26, 2019
By David Butcher, Staff Writer, MasterControl
Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.
March 21, 2019
By David Jensen, Staff Writer, MasterControl
Cloud technology has reached a level of maturity where many regulated organizations are discovering that operating in the cloud is becoming essential, rather than an option. A new white paper discusses the benefits of moving to the cloud and how cloud service providers are making the migration process smoother and faster.
March 19, 2019
By Beth Pedersen, Staff Writer, MasterControl
Beer has long been a staple beverage in human society. Beyond its taste and nutritional characteristics, beer’s greatest virtue is its ability to create shared social experiences for people the world over. To quench their thirst for innovative flavors, local goods and the highest possible quality, today’s beer drinkers are turning to craft beer in droves.
March 13, 2019
By Linda Chatwin, Esq., RAC, Sr. Customer Solutions Consultant, Health Sciences Division UL
As new technologies evolve, the device requirements for medical device companies in various global markets has become more complex and nuanced. To be successful in key markets around the world, device makers need to study these regulatory environments and develop a strategy to more seamlessly and efficiently acquire regulatory approvals.
To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts
February 28, 2019
By Heather McArthur, Sr. Director of Content Strategy, MasterControl
For many clinical, quality and manufacturing professionals, a change in process or technologies can be hard. But now, more than ever in life sciences, there is a need to digitize and move off paper-based or hybrid solutions. Through small automation pilots, the pains of transformation get eased while opening up opportunities that unlock a wealth of data-driven insights.
February 27, 2019
By Sarah Beale, Staff Writer, MasterControl
Millennials may be stereotypically known for ruining things, but they could actually be saving manufacturing. This industry is undergoing a digital transformation that requires employees who are very tech savvy – such as millennials.
February 26, 2019
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.
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.
