Hi everyone,
I have an issue with equipment which is moveable or can be easily relocated like: labels printer, small ultrasonic washer or device on wheels. Correct me if I am wrong, but is it acceptable to qualify this kind of equipment once and then in case of location change it may be noted in the logbook?
When I write about location change I meant the change in the same production area (floor).
I would appreciate any help,
Marta
If there’s no risk to moving the equipment then there are probably no re-validation needs. It might be a good idea to do a short risk analysis, considering anything that could be affected by the move (unplugging, plugging in to different power source, bumping / jarring during transport, etc.) to provide justification for not re-validating.
Logging the location change would be an asset management issue, not a validation one.
Thank you for replay.
And what do you think about re-validation of the computerized system installed on the PC after PC re-location (from one desk to another - the same production area)?
What would be the risk? PCs are designed to be power-cycled (and moved) so I don’t see how the software would behave any differently. If the PC boots up after relocation, it’s probably ok. Any failure would be obvious, I think.
We have validated mobile equipment quite easily. During the PQ stage we do batch 1 at location 1, batch 2 at location 2 and batch 3 at either (to suit). Provided the results are all passing, we accept that the equipment can be moved without compromising the outcome / results / product. Cat