We are very familiar with the requirements for validating software systems in the pharmaceutical industry (based on AMG, CFR 21, GxP etc.). And we will also be happy to support your efforts for qualification/validation of SkillCon 2010 in your company, as an example.

Extensive documentation

We would be happy to provide you with all our extensive documentation (in English) concerning SkillCon 2010, to facilitate your system validation and IT qualification. Since SkillCon 2010 has been designed for the regulated industries from the very beginning, the following documentation is of course always available for review, and is continually updated:

Risk analysis

User requirements specification

Use cases/functional specification

Test cases

Traceability matrices (all possible combinations or complete traceability throughout all levels)

Test logs of automated software tests

Extensive automated tests

We make our completely automated functional interfaces/software test available to you of course. They are an integral part of our testing framework, and built into our automated “Continuous integration” processes, along with the unit/regression tests. Upon request, you may obtain the test logs of each latest version of SkillCon 2010 as well.