I’m working on some validation scripts for Client/server application
I have some queries regarding executed validation scripts
1 ) If I execute my OO scripts on certain system (Test Run #1) and capturing evidences for the same…in between if I found some deviation & I resolve it and starts execution of oq scripts (Test run # 2) which is successfully finished ….Now I prepare Validation Report which will list down all my Test run 1 & 2 evidences and executed oq scripts
So how significant is this in conjunction with Validation / Compliance to maintain both test runs results and evidences
If my system for which constantly changing time to time after production so in this case how to manage system’s Validation ….can any one suggest me some options ?
On 1, Always document everything that happens. Auditors do not expect
perfection but they do expect to see how any given situation was
resolved. Your company should have a detailed deviation procedure
outlining the step by step process. All deviations are not created
equally so I suggest putin a classification system in there so you are
not over-reacting to very small easily resolved deviations like protocol
generation errors.
On 2, Validation is a snapshot of a system when it was validated. If
changes are made they simply need to be documented in a controlled manner
through your change control system, if the change really effects the
system, validation of your chages should be done. Your change control
system should allow for this.