Hi,
we have a computerized system which is not stable recently, the vendor suggests us to re-install the SCADA. Shall we re-qualify the system after the re-installation? Is it acceptable just to do some check to verify the software name, version number , access control, etc?
Thank you.
Ben
Do a risk-based analysis to establish re-validation needs and to document decision rationale.
Most likely, you’ll come to the conclusion that you can confirm the installation (properly performed) and run some regression tests of the more critical functions to put it back in a validated state.
Of course, if you have procedures that describe what you should do in such a case, you’ll need to follow them.
[quote=yodon]Do a risk-based analysis to establish re-validation needs and to document decision rationale.
Most likely, you’ll come to the conclusion that you can confirm the installation (properly performed) and run some regression tests of the more critical functions to put it back in a validated state.
Of course, if you have procedures that describe what you should do in such a case, you’ll need to follow them.[/quote]
Dear Yodon, much appreciated, thank you very much for your great advice.
Regards,
Ben