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.
June 6, 2023
By Ave Love, Staff Writer, MasterControl
In order to implement reliable strategies to route and resolve quality events before it’s too late, it’s essential to establish a quality management system (QMS) with advanced quality event management (QEM) processes. Learn the basic definitions, most common events, best practices, and tools to help you optimize your resources and be prepared for the next unplanned quality event.
May 31, 2023
By Greg Waldstreicher, Chief Executive Officer, Botable
Is it possible to harness the power of artificial intelligence to supercharge quality management? Absolutely, says Botable CEO Greg Waldstreicher. In this post, he explains the ways AI is redefining quality management, the advantages of embracing AI tools, and strategies for successfully integrating AI into existing workflows using real-world examples.
May 30, 2023
By David Jensen, Staff Writer, MasterControl
It’s no secret that relationships can be complicated — even downright unhealthy. Figuring out where you stand and constantly having to decide your next course of action is exhausting. If you’re in life sciences manufacturing, you’re likely in an unhealthy relationship with paper batch records. Where is your relationship with paper headed? Take this quiz to find out.
May 25, 2023
By David Jensen, Staff Writer, MasterControl
Pharmaceutical and medtech manufacturing are among the most innovative industry sectors. However, despite being on the cutting edge of scientific advancements, many organizations currently function with outmoded manufacturing operations. This post highlights a webinar that discusses the importance of digitization in manufacturing and why companies in both industries are rapidly deploying manufacturing execution system (MES) solutions.
May 23, 2023
By Brian Curran, Senior VP of Strategic Growth, MasterControl
The manufacturing world has a problem, and that problem is paper. Make the switch to electronic production records and you open yourself up to a whole new world of data analytics that make it possible to improve production.
May 17, 2023
By Sarah Beale, Staff Writer, MasterControl
Problematic quality processes can cause a rift between you and your auditor. If these issues aren’t addressed, you might find yourself dealing with the silent treatment. This quiz can tell you how things are going with your auditor.
May 16, 2023
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences
Do you have difficulties knowing which root cause analysis tool you should use to handle deviations? Or maybe you struggle to write concise investigation reports that ensure the right CAPAs are implemented to fix the causes of deviations? MWA Consulting’s Lisa Helmonds is here to help. In this deviation management overview, she describes best practices for initiating the investigation process, starting with how to characterize a deviation, how to define problems clearly, and best tactics for performing investigations.
