Author: Jayme Brace

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...

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...