Electronic signatures
Clarity allows electronic data to be signed using electronic signatures that are unique to each individual, cannot be reassigned or reused, and cannot be altered. This feature is required by 21 CFR Part 11.
Chromatograms in Clarity can be signed either under a Clarity user account or using a certificate. The certificate must include a private key protected by a password known only to the particular user, and the password must be entered each time the certificate is used.
Note:
Certificates used for electronic signatures are not part of Clarity installation package. They must be obtained from an authorized certification authority. DataApex does not issue certificates for electronic signatures.
When using third-party certificates, ensure that each Windows user account used on a given computer has its own certificate installed in its Personal store. If multiple certificates for different Clarity users are installed under a single Windows account, there is a risk that chromatograms could be signed using another user’s certificate. This is because Windows prompts for the certificate password only the first time a certificate is used during a session; subsequent signatures may reuse the same credentials automatically.
Each Clarity user should therefore use a dedicated Windows account with their own certificate installed in the personal certificate store. This setup is required when Clarity operates in a regulated environment using certificates issued by third-party certification authorities.
As an alternative, Clarity supports signing chromatograms using the credentials defined for each Clarity user through the Sign as Current User option in the Sign dialog.
To set the certificate to a particular user,