Installation Operation Performance Qualifications

Validation is the official sanction of your process system or process equipment. IQ/OQ/PQ is a regulatory requirement and must be completed prior to using the process for GMP purposes.

The key to a successful validation that you can defend to the most difficult of auditors is through the use of experienced personnel with a wide range of knowledge who can determine the correct validation parameters through scientific means and assure your process is robust.

QPS can help you troubleshoot your validation projects, analyze your PQ data, help you find solutions for those pesky difficult validations, or even perform your IQ/OQ/PQ.

QPS's industry experience includes successfully defending a wide range of validation projects to both FDA & European regulatory agencies. We can help you with your pre-audit preparations. Just ask us about our solution to those nested stopper validation questions.


Sample Documents

We write and execute IQ / OQ / PQ documents according to your Master Plan.

Available for Download: OPERATIONAL QUALIFICATION (OQ) PROTOCOL