The validation of any computer system in a regulated environment is always a tricky task with so many areas to cover. Not only do you have to ensure that the application adheres to 21 CFR Part 11 but it must also be validated to ensure that data integrity is not compromised throughout it’s life cycle.
To help you successfully validate a computer system remember the following:
http://learnaboutgmp.com/7-top-tips-validating-computer-systems-regulated-environment-video/