Good morning!
I have been tasked with the validation of our eQMS, which is a cloud based out of the box solution. As part of the validation, we need to create our own user requirement specifications (URS) and Process Qualification (PQ).
I have several questions that I am struggling to answer, and would greatly appreciate assistance.
1) For the PQ, should observed results be a screenshot, or is just stating the result acceptable?
2) For the URS, how would risk be assessed e.g. 'authorised reader shall be able to access and read controlled documentation within the system' - would this be high, medium or low?
I suppose the biggest issue we would have with if the system went wrong would be that we couldn't up-revision any documentation without being in breach of our work instructions. We do not rely on the system for anything directly relating to production or patient safety.
Thanks for your help
I have been tasked with the validation of our eQMS, which is a cloud based out of the box solution. As part of the validation, we need to create our own user requirement specifications (URS) and Process Qualification (PQ).
I have several questions that I am struggling to answer, and would greatly appreciate assistance.
1) For the PQ, should observed results be a screenshot, or is just stating the result acceptable?
2) For the URS, how would risk be assessed e.g. 'authorised reader shall be able to access and read controlled documentation within the system' - would this be high, medium or low?
I suppose the biggest issue we would have with if the system went wrong would be that we couldn't up-revision any documentation without being in breach of our work instructions. We do not rely on the system for anything directly relating to production or patient safety.
Thanks for your help