Auditing Systems for 21 CFR Part 11- Validation and Qualification – What are differences between Validation and Qualification?

1.53K viewsFDA
0
Changed status to publish
0

In terms of computer systems, qualification is demonstrating that the component is installed and operating to its correct parameters. Validation is determining that the process will consistently produce the desired output. So in a manufacturing environment if you qualify all the pieces of the equipment, you validate the batch process. So validation is going through the process qualification to individual pieces of equipment or components or applications. So that is what you see on the V- model: the right side is Installation Qualification, Operational Qualification and Performance Qualification; the overall process is validation

Changed status to publish