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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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?”
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Medical device companies, above all else, have one thing in common – regulatory compliance. Every one of the companies in the industry must comply with ISO and FDA requirements in order to stay in business. And these requirements are here for a very important reason - to protect the patients and consumers while ensuring the quality of products created.