DMSys is fully validated and compliant with 21 CFR Part 11. To assist our users who perform their own validation process, SigmaSoft International offers a User Validation Package. The package contains test plans, test scripts, test data and applications for use in documenting your validation testing for the system.

We can provide validation consulting to assist with the preparation of the user requirements documents, establishing SOP's related to DMSys, preparing a validation plan, running test scripts and preparing complete validation documentation.
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