The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
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While using a singular ITSM tool may be simpler, many organizations utilize multiple for their unique features. This often results in Jira Service Management, ServiceNow, and Freshservice working in tandem. Integrating these tools can be harder than it appears, but...
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