FDA and IT Validation – Part 1

We have safe medicine and medical devices the US largely due to the Food and Drug Administration oversight for all process involving producing such items.

IT process are included in this oversight which cover

• Installation of software
• Installation of hardware
• Performance of SW and HW against manufacturer’s benchmarks
• Expected performance regarding your use of the technology solution

Your implementation needs to ensure it is using the right equipment for the manufactures intended reason, can be traceable if there are any issues in the final product or solution, and is documented for future reference.

I will discuss Installation, Operational, and Process validation in future posts. For now, understand these necessary safe guards help ensure your project is a success for the way in which it was intended.