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21 CFR part 11 is a set of rules that specifies what is required for electronic records and signatures in order to be equivalent with paper records and handwritten signatures this means you can replace your paper based documentation and handwritten signatures with an electronic system and comply with FDA regulations first of all the requirements for signing documents electronically which is the focus of this video secondly the requirements for electronic record-keeping such as system validation and audit trail which we'll touch upon in another video these are the primary requirements in order to use electronic signature the user name and password are personal and cannot be used by anybody else the company must verify the identity of the individual that would be using the electronic signature the company must notify FDA about using electronic signatures when users use electronic signatures they must use two components username and password when signing records with electronic signatures both name date and time and the meaning of the signature must be applied there must be a policy for expiring passwords and there must be a procedure for lost and stolen passwords in this example I will show you how a parent 11 compliant electronic signature is used my colleague has updated a procedure which I will now sign by entering my password my electronic signatures automatically inserted in a PDF version of the document to summarize the requirements I have created this part 11 checklist which you can download here