A well-defined corrective and preventive action (CAPA) process is intended to identify problems, understand root causes, resolve issues, and take corrective action to prevent the recurrence of those problems. While the results are well worth the effort, designing and implementing a good CAPA process comes with some challenges. Here are some of the most common problems we see when companies are struggling with their CAPA processes.
6 min read
The 5 Most Common Problems with Your CAPA Process
By Paul Dionne on Wed, Dec 30, 2020 @ 01:19 PM
Topics: Compliance Quality Management Software Quality Management System CAPA QMS Corrective Action Preventive Action quality quality processes eqms software qms 4.0 problem qms software qms system
3 min read
Are You still customizing your QMS by modifying source code?
By Romeo Elias on Mon, Dec 05, 2016 @ 11:21 AM
It is surprising how many companies today are solving their need to customize their Quality Management Software by modifying source code. It is understandable why a company may want to customize a software to meet its unique business and quality processes. However, software platforms have evolved so much that there shouldn't be a need to change or add code to the vendor platform. Not only does this require expensive development skills and expertise, it also means that the company can no longer receive vendor upgrades to their platforms as they have branched out with their own custom solutions.