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 submitted from multiple modules...
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...
FDA 21 CFR 820 details the regulatory requirements medical device companies must comply with to manufacture and sell medical devices within the U.S. The regulation requires manufacturers to develop and maintain a Quality Management System (QMS) to document device...
When looking at a document management system, companies have two choices; paper based or electronic. In our experience, companies often tell us that, ‘they have been talking about an EQMS’ for a significant amount of time but have yet to make the transition. Given...
