Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Flowchart vs. process map, what do you choose to use? When it comes to mapping out a project, you’ve got several choices on how to visualize them. If you’ve had trouble deciding on a format for your ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

As we have previously covered on this blog, the primary purpose of Lean Six Sigma (LSS) methodology is to eliminate waste and reduce variation in manufacturing, service and design processes, thus ...

With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices. Unreliable data leads to unreliable validation execution. Quality ...