Hi
Just wondered if 13485 requires demonstrable security / integrity of systems used for electronic record keeping?
One of the departments under my MDR / 13485 scope (with Health Institution Exemption) for class 1 devices uses an MS Access database for some client records, relating to devices issued to them, including the manufacturing notes for custom made devices. There is no robust audit system inherent to the database to see what text changed / when / by whom, which means that records could effectively be altered. This doesn't seem appropriate to me. Printing the record to a time stamped PDF or similar may be a way of managing this. Any views?
Thanks
James
Just wondered if 13485 requires demonstrable security / integrity of systems used for electronic record keeping?
One of the departments under my MDR / 13485 scope (with Health Institution Exemption) for class 1 devices uses an MS Access database for some client records, relating to devices issued to them, including the manufacturing notes for custom made devices. There is no robust audit system inherent to the database to see what text changed / when / by whom, which means that records could effectively be altered. This doesn't seem appropriate to me. Printing the record to a time stamped PDF or similar may be a way of managing this. Any views?
Thanks
James