Verification of installed software (Q817)
Initiate by discussing with your QA and regulatory under which rules they will accept DoE made in MODDE as a basis for a filing.
BIG Pharma, such as AZ and Novartis, will audit Umetrics on site, review the Umetrics validation package and then validate the software before using it in anything that can be used in a filing. This may not possible for small companies.
As a small company you can ask for Umetrics validation package to use as a reference. Then use the section “Verification of installed software” to verify that the software installed at your site displays the same results as the Umetrics validation package.
The full validation package is free of charge for EP and MODDE maintenance customers and can be downloaded from our website. Send a request to your local sales representative to get a password.