What is the Difference Between Qualification and Validation?
There is a general saying:
“We qualify a system or equipment and validate a process”.
Qualification can be defined as the act of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and comply with specified requirements. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
Validation can be defined as documented objective evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications.
A system or equipment must be qualified to operate in a validated process.
For Example: “You qualify an autoclave, whereas you validate a sterilization process.”
