Auditing Systems for 21 CFR Part 11 – Validation – How do we keep our validations from becoming “War and Peace”?

There is no rule saying that your validation plan has to be of normal size. Adequate validation plans can even be of 2 to 3 pages. Depending upon the complexity of the system, there will be a set of critical parameters and you validate to the appropriate level. How much is appropriate is a matter of experience and there is also the risk assessment exercise.