November 8, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Masters Summit 2022 was a week of world-class education, insightful speakers, networking with industry peers, and fun. Find out which three themes repeatedly surfaced at this year’s event and what they mean for the future of medical device manufacturing.
Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.
November 1, 2022
By David Jensen, Staff Writer, MasterControl
According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.
October 25, 2022
By Sarah Beale, Staff Writer, MasterControl
After several years of delay, the U.S. Food and Drug Administration (FDA) issued its computer software assurance (CSA) guidance. Now that it’s out, here are some things from the guidance to keep in mind the next time a validation project comes up.
October 18, 2022
By David Butcher, Staff Writer, MasterControl
Rigid, hard-coded process configurations often make traditional manufacturing execution systems (MES) difficult to adapt and scale. The no-code configuration provided by modern MES solutions allows manufacturers to configure quickly and allows for the flexibility to adjust processes, material, and equipment changes for varying products.
October 13, 2022
By Ave Love, Staff Writer, MasterControl
Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.
October 11, 2022
By Johanna Blair, Staff Writer, MasterControl
Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.
October 6, 2022
By Michelle Tanner, CFO, MasterControl
If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.
October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
September 29, 2022
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Myrna Russell, Director of Quality and Audit Management, MWA Consulting, Inc.
To ensure you’re able to manufacture high-quality products and safeguard patient safety and data integrity, your organization must be able to effectively manage supplier quality. Find out how taking a risk-based approach and applying modern tools can improve your supplier management capabilities.
September 28, 2022
By Brian Freymann, Director of Health Life Science & Strategic Accounts, Microexcel, Inc.
Criminal opportunists are making a killing off counterfeit versions of life sciences manufacturers’ products. Learn why serialization is the key to getting fake products off the market and ensuring consumer safety.
September 27, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.
September 22, 2022
By David Butcher, Staff Writer, MasterControl
In fully or partially paper-based manufacturing environments, the production line is an underappreciated opportunity to make quality proactive rather than reactive. Digital technology in manufacturing can ensure quality at every step of production.
September 20, 2022
by Matt Lowe, Chief Product and Marketing Officer, MasterControl
As medical devices have grown increasingly complex, the need for cybersecurity guidance has never been greater. The latest guidance from the U.S. Food and Drug Administration provides updates to earlier versions that manufacturers need to know.
September 15, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
When it comes to avoiding FDA Form 483s and getting 510(k) clearance for medical devices faster, Northeast Scientific has cracked the code. Find out how the leader in medical catheter reprocessing has fast-tracked regulatory success and eliminated lag points.
September 14, 2022
By Becky Blankenship, Technical Writer, Cannon Quality Group
Every medical device company is faced with the challenge of navigating the FDA’s quality system requirements. Cannon Quality Group shares four compliance best practices that help make the regulatory road less rocky.
September 8, 2022
By David Butcher, Staff Writer, MasterControl
ISO 9001:2015 is one of the most recognized standards in the world. Among the goals of the quality management system (QMS) standard is to enhance requirements for addressing QMS change management.
September 6, 2022
By Johanna Blair, Staff Writer, MasterControl
The scope of a quality management system (QMS) can look very different depending on the size and goals of a company. However, following ISO 9001 standards for documentation can benefit any system.
August 30, 2022
By Johanna Blair, Staff Writer, MasterControl
The FDA is paying more and more attention to life sciences companies data management deficiencies. Following these five suggestions can help your organization prevent data integrity failures and strengthen CGMP compliance.
August 25, 2022
By Brian Curran, Senior VP of Strategic Growth, MasterControl
While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes.
