Slides on Process Validation from a presentation by an FDA Inspector from Florida on 5/11/01 are at the link provided. This presentation was given at a SUD Seminar. The presentation steps through Installation Qualification (IQ), Operational Qualification (OQ), and Process/Product Qualification (PQ).

It also discusses software and emphasizes:
“The output of the process may be fully verifiable and the overall process may not require validation however software used for automation or testing such processes should always be validated for its intended use.”