Specifc needs for ePRO system to be MHRA compliant?

Hi all,

A few questions regarding systems below. Your advice would be much appreciated!

1. We are keen to provide a potential ePRO system supplier (system currently suitable for non-reg studies only) with a list of system requirements for them to check whether their system can be upgraded/ amended to meet MHRA requirements with the potential to be used for regulated studies going forward. We are having real problems tracking down such details. It would be ideal to have some sort of checklist - does one exist? Is anyone happy to share their experience?

2. What exactly does a 'validated system' mean?
3. What validated system evidence would be needed for MHRA?
4. Is anyone happy to share examples?
5. Ideally we would like an MHRA inspector to assess the system and feedback. Is such a service available?

Thank you for your guidance.