Hello,
Is necessary to validate the software that compile the temperatures of
the reactors and make graphics, if the supervisor don’t take decision
with the results and the information given with this is only
informative.
Thanks in advance!
If the information is only informative, what is the information used for?
Let’s assume the software provides summary information. Will no one make a
decision from the summary information provide in the form of some sort of
report? Is this COTS software or bespoke?
There are two factors that will help answer your question. What will happen
if the software has bugs and what is the likelihood that the software has
bugs?
The question to ask is, “If this software were taken away, wouldproduction change at all? Does anyone use this software which compilesmeasurements to make a decision?” If someone says that you cannot takethis software away because they are using it, you need to ask follow-upquestions of that person or group.If taking this software away would make no difference to regulatedactivities, then validation would not be required. However, people whosay they are not using this software to make decisions sometimes turnout to be using software for decision-making when you phrase thequestion as taking away software that is not being used.