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Failed signatures log

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21 CFR Part 11 section 300 on regards of electronic signatures states: “Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management”.

Life Sciences Supply Chain Management captures the failed attempts to electronically sign records in the Failed signatures tab of the Database log form (System administration > Inquiries > Database > Database log), including the relevant information to identify the purpose of the electronic signature and the user who attempted to sign.

It is possible to configure a user that should be notified upon failed electronic signature attempts by selecting it in the Failed signature alert recipient field of the Electronic signature parameters form (Organization administration > Setup > Electronic signature > Electronic signature parameters).

The Failed signatures log report can be printed by clicking the Failed signatures log button in the Database log, and selecting the information to be included using the proper filters. Refer to the Advanced database logging feature for additional details.