October 20, 2020
By James Jardine, Staff Writer, 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 16, 2020
By David Butcher, Staff Writer, MasterControl
For manufacturers, supplier auditing is essential to gaining visibility into whether a supplier’s products and processes are adhering to a defined quality standard. According to Terrance Holbrook, MasterControl’s director of product, there are five often-overlooked actions that manufacturers can take to improve how they conduct supplier audits.
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 9, 2020
By James Jardine, Staff Writer, MasterControl
Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.
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, Staff Writer, 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 28, 2020
By James Jardine, Staff Writer, MasterControl
Knowing if a manufacturing process needs to be verified or if it needs to be validated is often a conundrum for medical device makers. Learn the difference between the two compliance-critical activities and circumstances when each is required.
September 25, 2020
By David Butcher, Staff Writer, MasterControl
The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.
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 16, 2020
By Director of Marketing, MasterControl
Besides cutthroat competition, manufacturers in the life sciences deal with strict regulatory and ISO quality requirements. Changes in processes need to be carefully managed to ensure that products stay safe and effective.
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, Staff Writer, 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.
