MHRA bemoans compliance issues with electronic health records.
“The move within the NHS from paper to electronic health record (eHR) systems has led to significant compliance issues in relation to Good Clinical Practice (GCP). There are potential serious consequences for Trusts that have an inadequate eHR system. These include: Trusts being rejected by commercial sponsors at site selection due to non-GCP compliant systems; the rejection of marketing authorisation applications (MAAs) or journal publications due to an inability to reconstruct the trial; and the unethical recruitment of patients to trials as the systems do not support the robust collection and retention of data. All of these issues may have a negative impact on the selection of NHS sites, and ultimately UK NHS Trusts/ Boards becoming less attractive places to conduct research (and the resultant financial implications of this, as well as reduced access to the latest research and medicines for UK patients). “
By effectively implementing BS 10008 prior to deploying software, all the issues raised by MHRA would be avoided. If you are in the process of or have already implemented your eHR system, call us to perform a Gap and Remedy Analysis. This exclusive service will not only identify compliance gaps, but also provide recommendations for resolution. Contact us today.