We are just beginning the planning process for our move to a new facility. We manufacture class I and II devices. Most of our manufacturing uses hand tools or fixtures. We have a some automated fixtures and equipment. No cleanroom involved (we contract his out). Any suggestions on how you would approach determining qualification/validation requirements would be appreciated.

Any other words to the wise if you have experience with moving would also be appreciated. Thanks!

We are just beginning the planning process for our move to a new facility. We manufacture class I and II devices. Most of our manufacturing uses hand tools or fixtures. We have a some automated fixtures and equipment. No cleanroom involved (we contract his out). Any suggestions on how you would approach determining qualification/validation requirements would be appreciated.

Any other words to the wise if you have experience with moving would also be appreciated. Thanks!The same way you did originally. If you haven't yet, look at the GHTF guidance (http://elsmar.com/Forums/attachment.php?attachmentid=5159&d=1148666394).

I once worked for a medical device company that moved its offices and manufacturing site.

Don't forget to update the details of your new address with the FDA and NB.

In general, the ISO auditor will inspect the new premises and will want to be sure that the move did not affect the QS of the company. Were customers/suppliers/distributors informed in advance of the move?
If a customer dials the old tel. number (of old premises), will he/she be informed of the new tel. number? How long will it take for the company server/network to be fully operational in the new premises? What happens in the interim? Whom does a customer/supplier contact when the move is in process and an emergency arises? Will the move necessitate re-calibration and/or re-testing of sensitive equipment? Do you need to change the location for the storage of company records or company documents (in your SOP) due to the move?

Most of the issues are straightforward and you should have no problem passing the audit of the new premises after the move.

Good luck with the move.

Asherlee