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hi im a senior consultant with csols ive worked on many computer system validation projects and i would like to share a tip with you an important deliverable in any software validation project is the trace matrix it can be used to demonstrate to regulators what has been tested and to easily find the testing for their review it can also identify any testing gaps that you may have id like to share with you how to make this document most effective for your use i recommend using a table format to build your trace matrix then you would go through and add all of your user requirements and break them out into functional and configuration elements from there you would trace each of these requirements to a test document in a test case a note of caution though consider when and how to add these configuration items to your trace matrix it could be more trouble than its worth if you need help with any of these validation tools such as the trace matrix fill out the form below and well be in to