Electronic signatures
It must be possible to sign electronic data in the Clarity with electronic signatures that are unique to each individual, will not be reused by, or reassigned to, anyone else and cannot be manipulated. This feature is required by 21 CFR Part 11.
Note:
Certificates used for electronic signatures are not part of Clarity installation and such certificates are to be provided by certification authorities. DataApex does not issue any certificates for electronic signatures.
The certificate that is to be used with Clarity must include the private key part with the password known only to the particular user and require entering the password at each use. To set the certificate to a particular user,
Cautions
It is necessary to bear in mind that in case of signing chromatograms with 3rd party certificate it is absolutely necessary to have the certificate of each Windows user account installed in the Personal storage of every Windows user account used on the PC where Clarity is operated. If there would be installed more certificates for more Clarity user accounts under single Windows user account it could easily happen that various Clarity users (defined through User Accounts dialog) could sign chromatograms with someone's else certificate. This situation can occur because it is standard behavior of the certificates in Windows environment to ask currently logged Windows user for password to his/her certificate only for the first usage of the certificate during individual Windows user account login session. Every other request to sign any chromatogram with already used certificate won't invoke any other request for repeated password insertion and the selected chromatogram could be signed using any available certificate for which its correct password was entered during current session of the logged in Windows user. To avoid that, in case of wish or necessity to use 3rd party certificates, it is necessary to have for each Clarity user account its separate Windows user account with unique credentials and 3rd party certificate installed in Private storage of this Windows user account. This condition has to be handled when Clarity should be deployed in regulated environment and there should be used certificates issued by 3rd certification authorities. There is still option to avoid this complication by signing of chromatograms by credentials defined for each Clarity user through option Sign As Current User in the Sign dialog.