Do You Have to re-validate a computer, just because you have relocated it?

If you have a piece of equipment that your risk assessment has decided requires validation in accordance with cGMP requirements. It is mandatory that if that validation status is altered in any way, then the equipment must be revalidated. You cannot pick and choose, you must follow through the requirements of your own risk assessment. However you can use this risk assessment to set the scope of validation required.

Anyone who thinks they can move computer equipment around with no regard to the new location, is a person of very limited experience and little or no engineering knowledge. Radio Frequency Interference (RFI) is a serious problem in industry, and all validated equipment installations must be verified as immune to RFI, emitted from other equipment, that may be used in the installation area (electric motors – intermittent electric supplies - mobile phones - hand held radio’s used by security/maintenance/contractors - local transmitters taxis/police/firemen).
This is a mandatory requirement.

Out of literally hundreds of cases, here are just two, for this Validation Online Blog;
On the final tests at Sizewell B nuclear power station, we found that as soon as you keyed one of the maintenance hand-held UHF radios, the carrier signal switched the main emergency battery bank to maximum charge, and tried to cook them. When all else has failed this battery bank is there solely, to close down the reactor safely. The charging system controls had to be completely redesigned.

Two years ago we attended Jesus College in Cambridge regarding data corruption in one of the labs. This corruption had been investigated by literally dozens of electrical companies. After listening to the history we decided to install electrical supply and gauss monitors throughout the lab. After a week the records were analysed – everyone was stunned by the findings. We went on to analyse all the rooms that were in use, then marked-up the building drawings and the room doors as to their suitability for computer use. 15% of the rooms were condemned. The regulators are well aware of these problems, subsequently, they do expect RFI studies to have been carried out on all validated electronic equipment installations, and this is not the only requirement they expect.

1 comment:

sanjaya dash said...

When all else has failed this battery bank is there solely, to close down the reactor safely. The charging system controls had to be completely redesigned.
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