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.
We invite you to download our paper on the topic of 483 Observations.
Integrating engineering with manufacturing doesn't have to be difficult. This downloadable white paper from PTC and SPK discusses how to successfully integrate Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) to benefit your business. You will...
Digital transformation and cloud adoption don’t have to be a hassle. With the new flexible solution from Microsoft, organizations can meet diverse needs by modernizing their workflows. This solution in partnership with VMware is called Azure VMware Solution. Learn...
When researching cloud computing services, there are many key components to analyze. A main factor many organizations look at is the resiliency of a service. Resilience is about how well a system can recover from a disruption or system failure. It can range from...
Confluence by Atlassian is an amazing tool for project management. However, it can be easy to accumulate a mess of attachments and pages in the workspace. Although there are some manual ways to keep Confluence tidy, Revyz.io has released a simpler solution. Revyz.io,...
