Hi All,
We are planning to shift our office from one location to other location in a same city. I have few doubts about the validation of the software.
If I change the server room location (Physical location), what would be the impact on Software Validation? Is it required to revalidate the software again ?
What should i document? (change control, IQ, OQ, PQ, Impact Analysis)
Thanks,
Bhoomi Banerjee
Let’s start with a question: why do you have doubts about the validation (after the move)?
Use that to help guide your answer about whether to validate or not. It’s a bit difficult to say definitively given the limited information you provided about the move.
In one respect, unplugging a computer from one location and plugging it in another doesn’t, on the surface, change anything. There are other aspects to consider: is the software dependent on a network configuration and is that changing? Are there any other changes as a result of the move?
At a minimum, you’d probably want to take the above questions (and any others you can think of) and do a risk analysis. Let your risk analysis drive the (re)validation effort. Even if there are no risks identified that could impact validation status, you’ll probably want to do some minimal testing just to be sure.
Hi,
Absolutely in agrrement with Mr. Yodon. Assessment document should be the basis for determining the validation effert. Very right thoght stream generated Mr. Yodon, Greetings !