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.
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Paper has forever been the universal proof of compliance.
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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.
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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).