Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you can manage non-conforming products with ease. It easily tracks products through all phases of the nonconformance process: description, analysis, investigation, decision, closure, and...
The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but FDA’s oversight of these products is also increasing1. FDA currently regulates dietary supplements Under the Dietary Supplement Health and Education...
Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has the functionality to manage the entire CAPA process – even those CAPAs that originate in other systems. A request can be...
CAPAs are often the most dreaded task to complete and the words “open a CAPA” can bring audible sighs and groans, but CAPAs are an important tool in improving the quality of products and processes. A good CAPA system can...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software...
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many...
With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a new medical device era. In our previous blogs AN UPDATE ON FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM and MODIFICATION AFTER INITIAL REVIEW AND...
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be sold in Europe comply. We’ve been highlighting many of the new requirements in our blogs, including: INTRODUCTION...
Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...
A root cause is a factor which caused a nonconformance and should be permanently eliminated through process improvement. Finding the root cause is done through root cause analysis which is a term describing a collective of approaches, tools, and techniques...