Unlocking the Power of eSignature Legality for Pharmaceutical in the United States

How to eSign a document: e-signature legality for Pharmaceutical in United States

welcome here are the 9 basic requirements for electronic signature as per 21cfr part 11 subscribe to channel for more informative content what is electronic signature a set of symbols that is as unique and legally binding as a handwritten signature but that is used to sign records in a computer system are called electronic signature [Music] which information shall be associated with electronic signature anytime an electronic record is signed the following information must be visible and associated with the signature first printed name of signer second date and time of signature third meaning of signature example content is accurate format is correct data calculations were verified for how long electronic signature shall remain connected with the record any kind of signature ink or electronic executed to an electronic record must remain connected to that record forever it can't be removed covered or erased transferred Etc for how long electronic signature shall remain connected with the record any kind of signature ink or electronic executed to an electronic record must remain connected to that record forever it can't be removed covered or erased transferred Etc is it required to have unique electronic signature each person must have unique electronic signature that has never been and never will be used by anyone else before someone can use an electronic signature his or her identity must be verified is it required to change password time to time answer is yes password must be checked recalled or changes from time to time what should be done if password is stolen or lost if the password or device is lost or stolen it must be de-authorized and a secure replacement must be issued thank you what should be the action plan in case if unauthorized attempts are done to access unauthorized attempts to access user IDs or passwords passcodes must be detected and reported to the appropriate person or group in the organization for investigation purpose [Music] what qualities are expected from electronic signature authenticity Integrity confidentiality irrefitability that is no way to deny that record is genuine these qualities are expected from electronic signature [Music] keep watching farm grow subscribe to channel for more videos related to our pharmaceutical industry [Music]