We are extremely familiar with the requirements relating to the validation of software systems in the pharmaceutical industry (based on AMG, CFR 21, GxP and so on). We would also be happy to provide you with support in this area – e.g. with the qualification/validation of SkillCon 2012 in your company.

Extensive documentation

We would be happy to provide you with extensive (English-language) documentation about SkillCon 2012 for your system validation and IT qualification.
As SkillCon 2012 has been developed from the outset particularly for the regulated industry, the following document is naturally available and is continuously maintained:

• Risk analysis
• User requirements specification
• Use cases/functional specification
• Test cases
• Traceability matrixes (all possible combinations or complete traceability across all levels)
• Test logs for automated software tests

Extensive automated tests

You naturally also have our fully automated functional interface/software tests at your disposal. These are a fixed part of our test framework and are integrated in our automated "Continuous Integration" processes together with the unit/regression tests. On request, we also provide the test logs of the most recent version of SkillCon 2012.