I would like to rain on your parade here a little bit. Computerized System Validation, as it is called by the Regulations, pertains to activities that are regulated by Title 21 of the Federal Regulations under the Food, Drug and Cosmetic Act. Usually it is about records of Clinical Trials, consent forms, qualifying investigator sites, analytical records of producing the drug substance, and quality systems in any of the other processes the results of which the Regulations want you to submit to get marketing approval. In particular, Part 11 explicitly regulates how you create, modify, maintain, or transmit electronic records that are submitted as part of the Regulation in lieu of paper records, and electronic signatures that you use to control these records in lieu of paper signatures. Read the regulation, it is pretty clear (and I have been in that business in my prior lives for too a long time, I can sing this in my sleep).
No observational research is regulated by the Regulation. The creation, modification, maintenance and transmission of the records (databases) are done by entities not regulated by the FDA (EMR vendors, insurance companies) for purposes not regulated by the FDA. If you want to use them as records for Clinical Trials - that's a different situation. But we are not talking about that. There are also no electronic signatures whatsoever. So, observational research has the same status as general drug research - not covered.
So, I am not saying we should not validate the system in the sense of having a robust QA which tests all aspects of what we put out and properly document that. But let's keep Part 11 and all that stuff out. We would never be able to do it for the above reasons anyway, because we don't control the records.
I would declare this exact thing in the document Martijn started and will end up on the website somewhere. Let me know, and I'll do it.