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.
April 13, 2023
By Bryan Ennis, Co-Founder & CEO, Sware
With innovative technologies accelerating the speed with which computer systems can be validated, the decision to shift gears into Validation 4.0 sounds like a no-brainer. So why do so many life sciences companies struggle to find a starting point for implementation? Sware founder and CEO Bryan Ennis offers a proven roadmap for modern computer system validation success.
April 6, 2023
By Ave Love, Staff Writer, MasterControl
It can be difficult to articulate what patient centricity means for pharma, let alone the benefits. Read this post to gain a clearer understanding of this relatively new approach to quality management, where it originates from, and practical ways to align your quality management system (QMS) with patient-centric principles.
April 4, 2023
By Johanna Blair, Staff Writer, MasterControl
Paperless automation makes the mundane tasks of our daily lives easier. It can be even more powerful when used on the shop floor. Replacing paper logbooks with electronic logbook software can bring not only greater efficiency for manufacturers, but also bring them closer to complete digital maturity.
March 31, 2023
By David Jensen, Staff Writer, MasterControl
At MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organization can learn from the experience of others in overcoming production gaps.
March 29, 2023
By Becky Blankenship, Technical Writer, Cannon Quality Group
Medtech startups face countless obstacles in their quest to achieve compliance and get products to market. While most recognize that modern technologies will enable them to reach their goals faster, it can be difficult to know when the time is right to invest in new solutions. Read on to learn four good reasons why a medical device startup should implement an electronic quality management system (eQMS) sooner rather than later.
March 28, 2023
By Ave Love, Staff Writer, MasterControl
With the anticipated harmonization between the ISO 13485 standard and the U.S. Food and Drug Administration Quality System regulation (21 CFR Part 820) coming closer to fruition, it’s time for medical device designers and manufacturers to ask themselves a few questions, not the least of which being, “Am I ready?” and “What does it mean for me?” Another great one is this: “Is there a software solution that can make this easier?”
March 23, 2023
By Johanna Blair, Staff Writer, MasterControl
Discover five often overlooked steps that can make your next supplier quality audit a more productive experience. Gain the major benefit of superior visibility into supplier performance and keep your supply chain moving.
March 21, 2023
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
Navigating and adapting to constant change requires more than a checklist mentality. Dr. Nancie Celini, president of Think OCM, explains why change management assessments must include mindful considerations and offers examples of the types of assessments that are ripe for a mindful approach.
March 16, 2023
By David Jensen, Staff Writer, MasterControl
To stay current with trends and gain a competitive edge in the life sciences market, manufacturing organizations collect a lot of data from various sources. For this level of data gathering, companies not only need more storage capacity, but they also need data storage technology that allows for rapid search and retrieval. Find out why industry leaders employ a data lake to store and manage large volumes of data.
March 15, 2023
By Steve Gompertz, Partner, QRx Partners
Regulators expect life sciences companies to take a risk-based approach to supplier management. But with so much supplier information to handle, how does an organization know which risks have been properly evaluated and controlled? QRx Partners’ Steve Gompertz examines the three critical phases of supplier management and explains how modern digital tools can streamline it.
March 14, 2023
By Sarah Beale, Staff Writer, MasterControl
Connectivity offers many potential benefits to medical devices. Unfortunately, that connectivity also presents risks. That’s why regulators are coming out with cybersecurity guidance documents for medical device manufacturers.
