Hi

I would agree with Rashmi regarding raising a QI however if their is no effect on your business process and your BCP works and the downtime goes to plan then it could be argued that their would be no requirement to log it as a planned LIMS downtime is an opportunity to exercise your BCP which should be part of a sites self inspection programme. Its then only a case of logging the failures that you experience as QI's.

If a site knows what has changed and how this change may or may not affect their business processes then the decision to re validate is up to the site based on the impact and risk assessment of the planned changes. If it is deemed to be minimal then it may be prudent to carry out a mini validation such as running through a sample from testing to issuing and fating a blood component. Sites will need to assure themselves that just because another department says that their wont be any changes that this is truly the case to avoid any unexpected surprises.

I hope this helps.

Kind regards

Mike