September 16, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Medical device companies can take a risk-based approach, which simplifies regulatory compliance while alleviating concerns about speed-to-market and new device clearance overhead costs to maintain compliance.
September 14, 2021
By David Butcher, Staff Writer, MasterControl
Medical device manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers. Quality agreements can go a long way to demonstrating the kinds of control that manufacturers have over their suppliers.
September 13, 2021
By Sarah Beale, Staff Writer, MasterControl
Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.
September 10, 2021
By David Jensen, Staff Writer, MasterControl
With the roll out of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), an increasing number of harmonized standards are out of date. This post addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting compliance with the new regulations.
September 9, 2021
By Dr. Dirk Stynen Owner, President and Principal Consultant, Qarad
Electronic instructions for use (eIFU) are just as compliant as paper ones, but any implementation of a new system is going to affect existing ones. In particular, the quality management system (QMS) will need to be updated in certain areas to prepare for the switch.
September 7, 2021
By David Butcher, Staff Writer, MasterControl
Though most manufacturers may recognize the benefits of digital transformation, many don’t see the roadmap. But there is a realistic path forward that helps mitigate or minimize many real barriers. The key is to make small changes in areas where you will see the biggest impact.
September 3, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
CAPA documentation failures are the most common citation in Form 483s that the FDA issues to medical device manufacturers. Learn five prudent measures you can take to ensure your CAPA documentation meets regulators’ expectations.
August 26, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Global pharmaceutical compounder Fagron is closing in on its goal to align quality across 66 sites worldwide. Discover how expanding the use of its cloud-based quality management system (QMS) to more business units is turning the company’s quality dreams into reality.
August 24, 2021
By Sarah Beale, Staff Writer, MasterControl
Gut instinct doesn’t cut it when making business decisions — especially in businesses that revolve around compliance and consumer safety. Hence the emphasis on big data and making data-driven decisions. It’s easy to say you want to use data, but to use it effectively you first need to take a step back and look at the bigger picture.
August 23, 2021
By Hitesh Patel, Managing Consultant, Enterey Consulting
When approaching the implementation and integration of a new system, you need a method to assess and distill a complex problem down to a simple process – these five steps.
August 19, 2021
By Samir Patel, Project Lead - Digital Systems, Sequence
Data integrity in the drug industry is a vital element to ensure the safety, efficacy, and quality of drugs. Data integrity has remained an industry buzzword for many years, but the experience the industry has gained from shortened timelines of COVID-19 vaccine development and manufacturing has further strengthened its importance.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
August 12, 2021
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.
August 11, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
The roles of regulatory operations professionals in the life sciences aren’t much different than those of air traffic controllers. They’re both focused on ensuring the safety of patients or passengers. Find out why regulatory operations experts are critical to companies’ speed of success and discover how advanced digital tools enable them to get products to more markets faster.
August 6, 2021
By David Butcher, Staff Writer, MasterControl
Life sciences manufacturers' production processes should be assets, not liabilities. Yet too many manufacturing companies continue to allow their batch records to become liabilities by using manual, often paper-based systems that are error-prone, disconnected, and limited in the operational insights they provide. Here are three common batch record challenges manufacturers encounter and some practical ways an electronic batch record (EBR) solution can resolve them.
August 4, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Regulatory shifts and the ever-accelerating pace of innovation are necessitating a new approach to clinical investigations of medical devices. Learn about the unique regulatory pathways that devices traverse and why recent updates to compliance standards are calling for risk-based clinical strategies.
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.
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