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.
May 9, 2023
By Sarah Beale, Staff Writer, MasterControl
MasterControl original research shows that digital quality management still has a long way to go. To help you use this research to your advantage and get ahead of the competition, we recently released a webinar, “Winners Only: 3 Steps to Compete in Digital Quality.”
May 2, 2023
By Sarah Beale, Staff Writer, MasterControl
Life sciences manufacturers have a hard time keeping up with digital trends. Electronic batch records (EBR) can greatly simplify production, but getting them traditionally required investing in an expensive, rigid manufacturing execution system (MES). This is no longer the case as a modern MES can provide the same benefits at a lower cost with easier configuration.
April 27, 2023
By Ave Love, Staff Writer, MasterControl
Functional relationships between manufacturers and their suppliers and vendors can lead to successful and long-lasting production operations. However, none of this can be taken on faith. Vendor compliance audits are key to maintaining both product and partnership viability that can operate well within compliance frameworks. Discover the key responsibilities, strategies, and tools necessary to extend your own quality management practices to your suppliers.
April 26, 2023
By Uday Veera, M.S., MBA, Director, CSV/CSA, Namo Solutions
Computer software assurance (CSA) is vital in manufacturing processes that rely on computers and automated processing systems. Namo Solutions’ Uday Veera explains why a risk-based framework provides the most effective CSA approach and offers tips to help manufacturers optimize their CSA efforts.
April 25, 2023
By Johanna Blair, Staff Writer, MasterControl
Cell and gene therapy manufacturers need modern digital solutions that can take paper out of the production process, connect their teams, and help them stay flexible. Learn how cell therapy pioneer Dendreon used MasterControl Manufacturing Excellence to do just that.
April 20, 2023
By David Jensen, Staff Writer, MasterControl
MasterControl recently conducted a study on the level of digitization deployed in pharma and medtech manufacturing. Find out how your company compares with your industry peers in terms of digital maturity and how to stay competitive in today’s market.
April 19, 2023
By David Howarth, Managing Director, iDE8 Ltd
With the advent of electronic quality management systems, AI, and other modern tools, medical device manufacturers are now able to optimize their operations to ensure that all products meet the highest standards. In this blog post, iDE8’s David Howarth explores the ways in which digital transformation is impacting medical device quality and continuous improvement.
Audits are never a fun experience, but you can greatly reduce the stress if you prepare beforehand. Passing your ISO 9001 audit is completely doable by following these steps.
