“ We have been using DataFax since 1993 and really believe in this approach. With DataFax we are able to keep on top of all of our trials, reviewing CRFs from all sites immediately after each patient visit. ”

Acceptance Testing

Computer software installation and acceptance qualification is an important part of every computer system implementation used in clinical trials. The expectation that qualification testing will be performed in the environment in which the software will be used is clearly stated in “Guidance for Industry, Computerized Systems used in Clinical Trials”, produced by the US FDA.

Clinical DataFax Systems Inc. recognizes the importance of demonstrating and documenting that DataFax operates as expected in each environment in which it is installed. To assist our clients in this task, we have created an Acceptance Testing Kit which is included (at no additional charge) on the DataFax installation CD. This kit consists of a pre-defined study and twelve modules that perform functional testing of the DataFax software in the installation environment. Each module includes step by step instructions, sample CRFs, and programs that detect differences between the observed results of the each test and the expected results. A top-level user interface makes the kit easy to use.

While the DataFax Acceptance Testing Kit does not includes tests for every possible option and combination of options that might be used, it does test the core functionality and most critical components of the DataFax software, and thus provides a good starting point for any acceptance test plan.