July 30, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation.
July 28, 2021
By Wolfgang Schmitt, Vice President, Concept Heidelberg
According to good manufacturing practice (GMP) guidelines, companies in regulated environments must adhere to regulations that apply to the development of health care products. For medicinal product manufacturers in the European Union (EU), the person responsible for batch certification and the majority of quality processes is the Qualified Person (QP). This article details the duties and responsibilities of the QP and explains why it’s important for U.S.-based companies to understand the QP’s role.
July 27, 2021
By David Jensen, Staff Writer, MasterControl
The COVID-19 pandemic has been disruptive. At the same time, it has elevated consumers’ interest in pursuing healthier lifestyles, such as tracing food supply chains and consuming more immunity-boosting foods. This post examines new trends in the food and beverage industry and how manufacturers are adapting by implementing digitized technologies.
July 22, 2021
By Sarah Beale, Staff Writer, MasterControl
Last year was nerve-wracking for most industries to at least some degree. Cannabis was no different. When everything shut down cannabis retailers were left wondering how they’d stay in business. Fortunately for the industry, cannabis was largely declared an essential business, which let them increase sales by 47% over the previous year.
July 21, 2021
By Sarah Beale, Staff Writer, MasterControl
In our upcoming webinar, we’ll talk about what we can do with artificial intelligence (AI) now and how it’ll change the future of quality and manufacturing.
July 19, 2021
By Lillian Erickson, Global Quality Manager, MasterControl Inc.
When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?
July 16, 2021
By David Jensen, Staff Writer, MasterControl
Five years ago, the International Organization for Standardization (ISO) published the ISO 13485:2016 standard. This post addresses the most common questions industry stakeholders have asked about the standard and its current status.
July 15, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Quality takes on a new meaning in the clinical manufacturing sector, where flexibility is critical and production hinges on rapid yet exacting adjustments. Discover how integrating quality early in the manufacturing process gives companies an edge in the fast-paced and highly competitive field.
July 13, 2021
By Dale Thompson, Staff Writer, MasterControl
If you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, ""about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average."" Here's a look at five critical ways that paper-based processes are eating into revenue.
July 8, 2021
By David Butcher, Staff Writer, MasterControl
A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.
July 6, 2021
By Dale Thompson, Staff Writer, MasterControl
Between helping to deliver a vaccine to the world, and rising demands in personalized medicine, the contract manufacturing industry is traveling fast, but the market requires more. Digitization makes it possible to accelerate while delivering high-quality products to the market faster.
July 1, 2021
By Beth Pedersen, Staff Writer, MasterControl
If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?
June 30, 2021
By Arvilla Trag, RAC, Consultant, BioProcess Technology
Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.
June 28, 2021
By Sarah Beale, Staff Writer, MasterControl
In clinical trials, site monitoring is required, but the report about the monitoring isn’t always given the attention it deserves. Prepare your next monitoring visit and the report by following these five tips to success.
June 23, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Regulators are intensifying focus on risk-based compliance approaches and pharma companies must adapt to the shift. Discover why process digitization provides the surest route to compliant risk management and learn how to prepare for the increasingly risk-based future of regulation.
June 22, 2021
By David Jensen, Staff Writer, MasterControl
Maintaining compliance in medical device manufacturing is colossal and complex. Any number of things can slip through the cracks and fall into the lap of a regulatory inspector. MasterControl’s industry brief “Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments” helps companies identify and mitigate issues before they lead to extra work and costly delays.
June 18, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Natural and man-made disasters aren’t just terrifying – they can signal the death of your business if they lead to data loss, prolonged system outages, or downtime. Learn why cloud technologies take the panic out of disaster recovery and validation.
June 16, 2021
By Dr. Dirk Stynen Owner, President and Principal Consultant, Qarad
It is often crucial for safety that users have access to the correct instructions for use (IFU) when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented their eIFU solution in agreement with the requirements.
June 8, 2021
By Sarah Beale, Staff Writer, MasterControl
As companies learned during the pandemic, going digital is easier said than done. That’s why life sciences consulting firm Enterey uses a four-step process to help their clients transform their businesses. To walk us through it, we chatted with Manager Aimy Rehm about how to practically apply the steps and some potential scenarios companies may face.
