July 25, 2023
By David Jensen, Staff Writer, MasterControl
Additive manufacturing (AM), often referred to as 3D printing, is a useful technology that’s frequently used for product research and development in many industries. The medical device industry is seeing more additive manufacturing being used in commercial product development, offering significant value in the production of customized, fast-to-market devices.
July 25, 2023
By David Butcher, Staff Writer, MasterControl
Medtech manufacturing organizations face constant challenges around disruptive technologies, fast-growing amounts of data, and a changing regulatory landscape. As the use of advanced technology such as artificial intelligence (AI) and machine learning (ML) in medical devices in increases, so will new rules and regulations. To better navigate changing compliance requirements, manufacturers in the field of medical technology must leverage digitization in manufacturing to build quality assurance into production and improve data management across the product life cycle.
July 25, 2023
By David Butcher, Staff Writer, MasterControl
The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.
July 20, 2023
By Sarah Beale, Staff Writer, MasterControl
Like many great ideas, lean manufacturing is a seemingly simple idea that proves very difficult to implement. Its shortest definition is doing something in the most efficient, least wasteful way. Sounds simple, but when you get into the details, things can get complicated. That’s where data comes in.
July 20, 2023
By Ave Love, Staff Writer, MasterControl
Depending on the degree of paper processes still being used by CMOs and CDMOs, their range of motion, or flexibility, to change with current market demands will be limited. We can look to an ancient paper application that has begun to utilize technology and discover the scope of transformation that becomes possible in life sciences manufacturing by eliminating every sheet of paper.
July 19, 2023
By Ricardo Rengifo, President, dbs Software and Services
The emergence of digital forms and automated workflows has revolutionized operations and dramatically enhanced efficiency and productivity. In this blog post, dbs Software and Services’ Ricardo Rengifo explores the significance these modern tools have for manufacturing and quality professionals.
July 18, 2023
By David Butcher, Staff Writer, MasterControl
Manufacturers sometimes make the mistake of viewing automation or digitization in manufacturing as a replacement for workers rather than as a means of supporting and enhancing workers. In failing to invest in digital manufacturing solutions as tools to optimize people on the shop floor, manufacturers miss out on the real benefits of digital transformation, including time efficiencies, new business intelligence, and greater productivity.
July 14, 2023
By David Butcher, Staff Writer, MasterControl
Digital manufacturing solutions provide real-time data access and analytics that medtech manufacturers need to process vast amounts of data, make more informed decisions, and improve performance in production and quality.
July 11, 2023
By David Butcher, Staff Writer, MasterControl
Digital transformation initiatives were already underway among life sciences manufacturers before COVID-19 struck, but the volatility around the global pandemic brought to light the importance of digital technologies in the supply chain. Research indicates that companies digitized many activities 20-25 times faster as a result of COVID-19. Integrating digital technologies in the supply chain has enormous implications for life science organizations.
July 10, 2023
By David Butcher, Staff Writer, MasterControl
Even as manufacturers invest in system digitization and automation, the people responsible for production records have been left to manage paper, spreadsheets and other standalone systems to collect, record and interpret data relating to production and quality processes. By extending digitization beyond their core systems to their production records, manufacturers can gain a more complete view of their data, optimize manufacturing and ensure quality throughout the production life cycle.
July 6, 2023
By Ave Love, Staff Writer, MasterControl
Eliminating and preventing low-level quality events is the way to preserve your CAPA system and simultaneously work toward continuous improvement. Find out how establishing a culture of quality creates opportunities for all personnel to take ownership of quality and why the ability to incorporate verifiable data into vital processes is the key to their success.
July 4, 2023
By Dave Edwards, Executive Vice President, MasterControl
Many occupying the manufacturing C-suite have embraced the principles of lean manufacturing and continuous improvement because they affect their bottom line. Yet a large portion of manufacturers continue to rely on error-prone, costly document management and recordkeeping systems on the shop floor. Reap the greatest benefits from lean by embracing the digital transformation and upgrading your organization’s culture of quality.
June 28, 2023
By Micky Chorny, CEO and Co-Founder, Aligned Being LLC
The best way to have your quality team embrace a growth mindset is to make it safe to fail and to make it easy for everyone to get on board with progress. This article by Aligned Being CEO Micky Chorny recommends a few simple ways you can do this.
June 27, 2023
By Ave Love, Staff Writer, MasterControl
A new case study from MasterControl explores how one leading contract manufacturer was able to undergo digital transformation in their manufacturing operations to stay in the lead in the emerging market of personalized medicine.
June 22, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Maintaining data connectivity and process integration across the value chain is a big challenge, but it’s imperative for life sciences manufacturers who want to stay competitive. Find out how modern digital tools can help you close quality loops.
June 21, 2023
By Erika L. Roberts, MFS, Principal Consultant/Owner, ELR Lab Services LLC
Want to spend more time enjoying your favorite summertime beverage and less time worrying about your cGMP deviations? ELR Lab Services’ Erika Roberts explains why deviation management matters and shares expert advice on managing deviations smarter with modern digital tools.
June 20, 2023
By Sarah Beale, Staff Writer, MasterControl
Wanting to go digital in quality management is one thing — figuring out how to do it is a bit more complicated. To help you do that, we’ve created a quality management maturity model to gauge digital maturity and conducted research with your life sciences peers.
June 15, 2023
By Pankit Bhalodia, Partner, Healthcare and Life Sciences, West Monroe Partners, and Adam Welsh, Partner, Healthcare and Life Sciences, West Monroe Partners
If you’re leaving data untouched, you’re losing out on a critical business asset. Experts from West Monroe explore several ways emerging technologies are helping digitally savvy companies drive success and maximize the value of their quality data.
June 13, 2023
By David Jensen, Staff Writer, MasterControl
Over four decades ago, BioBridge Global climbed aboard a fast-moving biotherapeutic industry — never slowing in its mission to save and enhance lives through the healing power of human cells and tissues. This post details how the company implemented electronic batch records (EBRs) and an electronic quality management system (eQMS) to overcome its obstacles to fast deliveries of quality products.
June 8, 2023
By Becky Blankenship, Technical Writer, Cannon Quality Group
Can digital technology revolutionize the way your medical device company manages risk? Companies that embrace digital quality management are realizing dramatic increases in the safety and performance of their medical devices. Cannon Quality Group shares three ways digital technology can improve medical device risk management.
