December 15, 2020
By Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
December 14, 2020
By Dale Thompson, Staff Writer, MasterControl
Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.
December 10, 2020
By Sarah Beale, Staff Writer, MasterControl
All year we’ve been addressing connected quality data. Since we’re talking about connecting data across the organization, it makes sense that there would be advantages across the organization. Getting executive buy-in requires showing your C-suite how they’ll benefit from a digital transformation.
December 9, 2020
By Sarah Beale, Staff Writer, MasterControl
We recently sat down with North Pole CEO Kris Kringle to chat about how he took his operation from paper to digital. Turns out making presents for children all over the world requires a cutting-edge manufacturing solution.
November 17, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.
November 12, 2020
By Sarah Beale, Staff Writer, MasterControl
For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.
November 10, 2020
By Sarah Beale, Staff Writer, MasterControl
There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.
November 6, 2020
By Christine Park, Founder and Consultant, Christine Park & Associates
A robust, flexible quality management system (QMS) is a critical part of a business. Recent issues with COVID-19 illustrate why it is important than ever to integrate the QMS with the organization’s business continuity plan.
October 29, 2020
By Homi Dala, Consultant, Brandwood CKC
This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.
October 26, 2020
By David Jensen, Staff Writer, MasterControl
QuVa Pharma is a 503B compounding facility with a large catalog of medicines and a growing customer base. Read how the company has been improving its use of resources, efficiency and quality to keep up with increased production demands and tighter timelines.
October 21, 2020
By David Butcher, Staff Writer, MasterControl
Legacy technology can be a significant barrier to digital transformation. At Carestream Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms. The company is taking a platform approach to technology modernization, including electronic device history records (eDHRs), to transform manufacturing performance and quality.
October 20, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.
October 13, 2020
By Dr. Ginette M. Collazo, CEO, Human Error Solutions
CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.
October 7, 2020
By Sarah Beale, Staff Writer, MasterControl
Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.
October 6, 2020
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.
October 5, 2020
By David Butcher, Staff Writer, MasterControl
A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.
