Qualification and validation studies need pragmatism, with concise, easy to follow protocols which ensure that all critical tests are performed while justifying the omission of irrelevant tests.

Validation and qualification need not be complicated and with comprehensive plans and well written protocols, anyone can do it!

We can provide a gap analysis of your current validation status and can provide a suite of plans and SOP templates to control your qualification and validation systems from the User Requirement Specification to the Performance Qualification Report.

We have extensive experience in facilities and equipment qualification, cleaning validation, process validation and especially analytical method validation to ICH Q2. Click on the links for more information on each area.