I work in a clinical research within an NHS healthcare setting . We are changing our electronic patient record system and consideration is being given to how the source data which is contained within it can meet all the required standards.

I want to ensure that we are future proofing this as much as possible and also to ensure we have considered all the applicable standards.

Obviously GCP standards apply and some sponsors have expectations for us to meet the federal regs 21 CFR Part 11.

Is anyone able to point out whether there are any other specific trial related standards that are out there that we ought to consider?

Many thanks