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Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms.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.
To celebrate Manufacturing Day, we’re encouraging future manufacturers to look at some of the exciting trends happening in the industry. This includes organizations coming together to address COVID-19 and stepping into the world of artificial intelligence.
October 1, 2020
By Matt Brawner, Director of Sales Execution, Sequence
Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.
September 29, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.
September 23, 2020
By Eric Claude, MPR, Vice President Health & Life Sciences
When you experience an event such as a product recall or low production rates, resolving these issues can be challenging. Your best bet is to have a road map that helps you get to the root of the problem and recover quickly.
September 22, 2020
By Sarah Beale, Staff Writer, MasterControl
Life sciences manufacturing during COVID-19 has changed dramatically. That’s why we’ve worked with MedTech Association and MASSMedic to bring you a 10-part webinar series about how to scale and pivot during the pandemic.
September 17, 2020
By Matt Dell, Acting Head of Marketing, Outspoke
Cannabis supply chains need to deliver high-quality products with consistency and foresight. Using state compliance data, it’s possible to ensure supply networks and regulators have all the necessary information they need for greater visibility and collaboration.
September 15, 2020
By David Jensen, Staff Writer, MasterControl
As the COVID-19 pandemic escalated, urgency and adaptability became the theme for organizations as they were suddenly tasked with enabling their entire workforce to work remotely. This scenario has largely been the impetus for more companies accelerating their migration to the cloud.
September 10, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.
September 10, 2020
By David Butcher, Staff Writer, MasterControl
In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.
