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.
June 3, 2021
By David Butcher, Staff Writer, MasterControl
New technologies are enabling innovative advances in precision medicine. They are also generating vast amounts of data – across clinical studies, laboratories, patients, products, and more. As more enormous, disparate data sets are created, organizations need to be able to track, store, and analyze the information quickly and accurately. To fulfill the promise of precision medicine, organizations must harness all that data through greater connectivity and interoperability, increased visibility, and more data-driven insights.
June 2, 2021
By Philippe Charbon, President, Apsalys
Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.
June 1, 2021
By Sarah Beale, Staff Writer, MasterControl
The quality management career has its ups and downs. We’ve already explored how to get into quality — now Quality Engineer Natalie Weber shares the good, the bad, and the hilarious parts of the job.
May 25, 2021
By Sarah Beale, Staff Writer, MasterControl
The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.
May 21, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.
May 20, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.
May 19, 2021
By Dale Thompson, Staff Writer, MasterControl
All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.
May 13, 2021
By David Jensen, Staff Writer, MasterControl
More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.
May 12, 2021
By Cameron Loper, Digital Health Leader, MPR Associates
The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.
May 11, 2021
By David Butcher, Staff Writer, MasterControl
The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.
