R Package Validation Infrastructure

Validation
R Package
Software
Clinical Trials
GxP
Validation framework for rpact

At the beginning of the project we worked out a validation plan and a validation documentation template that was reviewed by our customers who signed our Service Level Agreement.

Take a look to the table of contents of the validation documentation. An essential part of the validation are simulations and unit tests which verify that the package works exactly as expected (Performance Qualification). The Installation Qualification on the pharma companies servers can be done easily by calling the rpact function testPackage() which executes all available unit tests and provides a test result report (execute ?rpact::testPackage under R for more information).

For the rpact project we have developed a validation framework and implemented as R package rpact.validator. This framework provides the following: