I am trying to Validate our WinNonlin 6.1 in a GLP lab. I got two concerns about its validation: (1) We use a licensed Validation suite 2.0 as a validation tool to validate our application, but we do not have any proof to show that Validation Suite 2.0 are certified. How could we defend ourselves for this challenge? Usually, we use a certified thermometer to calibrate the temperature chamber. (2) I got a headache on how to deal with PQ of the WinNonlin system, Does anyone have any recommendation on how to do this? Thanks!
Hi Kevin, In answer to your first question you can request from Pharsight a “Product Validation Statement” that is signed by our QA, Manager this may be a useful document to include in your files. You may request this either via your Account Manager or Support. For the second I think the user’s perspective is probably more applicable to your needs; I personally would take a risk based approach to avoid overkill. Simon. PS I forgot to mention that the next release of the validation toolkit (June/July) will work against both the Phoenix 6.2.1 & 6.2 releases