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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As the world transitions toward agile, decentralized cloud computing, numerous US federal agencies have aligned around a stringent set of common standards and practices for security and risk assessment known as FedRAMP.
7 min read
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).
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Quality isn’t negotiable, but some manufacturers think the process used to achieve it is. No matter which way you slide it, having a configurable quality management software is essential for your organization — and why an effective out-of-the-box system doesn’t realistically exist.
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When looking to replace manual processes with an eQMS Software solution, Quality Departments ask one fundamental question: “Do I want to change my standard operating procedures (SOPs) to fit the software application or do I want to modify the software to meet our unique SOP’s?”