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
8 min read
An Almost Paperless Approach to Quality Management
By Peter Hargittay on Thu, Dec 10, 2020 @ 01:25 PM
Paper has forever been the universal proof of compliance.
Topics: Paperless Office Compliance Paperless Document Control Quality Management Software Quality Management System quality quality data digital document management
3 min read
Staying HIPAA Compliant with QMS Software
By Selim Ozyel on Wed, Oct 28, 2020 @ 04:54 PM
For many companies in FDA regulated industries, including pharmaceuticals, medical devices, labs and life sciences, compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a critical requirement.
Topics: Compliance Quality Management Software Quality Management System CAPA QMS quality challeneges HIPAA Compliance HIPAA cyber-security
7 min read
Build or Buy? How to Buy QMS Software That Meets All Your Needs
By Peter Hargittay on Fri, Aug 28, 2020 @ 02:18 PM
The build vs. buy dilemma isn't new to businesses considering investing in a quality management system. After all, they often have very specific needs from their QMS solutions (depending on the regulations that apply to them, their desired process automation maturity and manufacturing velocity, their monitoring and analysis expectations, and their unique documentation and data processes, among dozens of other things).
Topics: Compliance Quality Management Software Quality Management System configurable QMS quality eqms eqms software configurability
2 min read
Quality Management Software: Cloud or On-Premises
By Peter Cutler on Fri, May 03, 2019 @ 06:00 AM