We are a small CRO conducting mainly non-GLP but also some GLP studies in the UK. We are looking to reduce the amount of paper volume going into our physical archive. The proposal is that we change our SOPs to allow for supporting email trails and reports to be held electronically instead, moving forward. We have an electronic archive where completed studies are moved and can no longer be edited (except by the archivist), and still intend to print the pages of reports which require a signature, which will be scanned and retained (physically), the scans will be used to make a PDF final report which will be held as the official version and archived electronically when the paper folder is archived.
Can anyone think of any issues which we have not considered, or any reasons we should not proceed with making a more hybrid system between paper and electronic? And whether we are required to inform the MHRA for such a change? Any assistance greatly appreciated!