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Move to electronic archiving of final reports

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  • Anon
    29/10/2020 12:11
    Hi, 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!
  • Wolfgang
    19/11/2020 14:10
    I have seen such hybrid solution more than once and it seems ok for me. The process should be clearly described in your SOPs. Care should be taken, that between the QA inspection of the (unsigned) report and the Addition of the scanned signature page no undue changes occur. This can be achieved by storing the report in a document Management System or a Directory with limited Access and/or unique versioning of the document.
  • RQA GLP Committee
    20/11/2020 09:22
    Dear Anon, Thank you Wolfgang for your useful response. This should be achievable. Conduct a risk assessment to identify where the potential impact to the studies may be. Then put into practice (and your SOPs) how you will mitigate these risks and fully document any decision making/discussions round the topic. It would be worth sending an email to the GXPLabs inbox and letting the MHRA know that you are changing systems. Remember that the data Integrity requirement is for any data that is generated electronically to be retained electronically.
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