This week’s roundup brings you the latest from the Life Science industry. In the news, we see the potential implications of Trump’s FDA pick on the medtech and biotech industries. Then, an article from MPO magazine sheds light on the benefits and best practices for corrective actions in the Life Sciences. Finally, EtQ’s blog guides us through everything you need to know when considering cloud software for your Life Science solution.
The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks.
But meeting FDA requirements around software validation and change control isn’t always straightforward, particularly if you don’t have in-house experts to guide the process.
With that in mind, let’s take a closer look at what’s required for initial validation, and how to use change control to maintain a validated Quality Management System (QMS).
This week’s roundup is focused on the Life Science industry. Read on for articles from Qmed and Quality Digest experts as they cover topics on the medical device tax and a different approach to data structures. We conclude by looking into the importance of risk management and setting risk parameters.
Ask any productivity guru, and you’ll find that effective prioritization is key to getting stuff done. Whether it’s focusing on the one most important thing you must get done today or using a tiered system to sort your to-do list, being able to separate less pressing items from mission-critical tasks is a hallmark of effective and efficient work.
In terms of safety and quality, risk can be an especially useful metric for prioritizing action. In this post, we’ll look at how using risk assessments throughout your quality process can help you better prioritize your activities.
This week’s Verse Roundup focuses on Quality. In this compilation, you will find information from sites like LNS Research, Quality Magazine and our very own Verse Blog. Topics range from quality management and its digital transformation, to Big Data and why quality is a journey, not a destination.
Quality and safety, regardless of industry, are not as far off from one another as you’d think. In fact, most organizations share long term goals and don’t even know it. Sure, short term goals may not always be the same, but in the long term they very well can be. In fact, how many of your goals are to maintain a culture of integrity, compliance and consider the needs of customers and stakeholders?
With that said, an effective organization is likely to share both a safety and quality cultural mindset.
This week’s Verse Solutions roundup consists of the latest industry news in the life sciences
industry. We have articles from FDA Voice introducing the Innovation in Medical Evidence Development and Surveillance System (IMEDS), from Quality Digest on keeping healthcare customers happy and we bring you 4 ways an automated system benefits life science companies.
Implementing a Quality Management System (QMS) is a great step in achieving and maintaining compliance, but it’s not enough. If you’re not using your software correctly, you can’t utilize its full potential.
Here are a few common mistakes people make when using quality software and what you can do if you have made one of these mistakes.
We start with some big news for agriculture as Trump names a new leader of the USDA. Then, we’ll see how research into smart technology can work to improve food safety. Finally, we’ll look at some sustainability trends in the food and beverage industry and how you can make sure your organization is keeping up.
MD&M West is the world’s largest annual medtech expo and conference. We’re excited to announce that we’ll be attending this year’s conference in Anaheim, CA from February 7-9th, where we will showcase Verse in booth #2147.
Here’s a list of 5 events you won’t want to miss.