Egnyte Sign GxP

For organizations in Life Sciences, standard electronic signatures often are not enough to meet strict compliance mandates.

Egnyte Sign GxP is a specialized signature workflow designed to help users meet rigorous global regulatory requirements, including FDA 21 CFR Part 11 and EMA Annex 11. It adds critical layers of security, authentication, and auditability to the document workflows, ensuring that the electronic records are legally binding and audit-ready.

Key Features of Egnyte Sign GxP

When a user sends or signs a document using the GxP enabled Egnyte Sign, it enforces several mandatory compliance checks:

1. Identity Re-Authentication: Signers are required to re-authenticate their identity at the exact moment of signing.
2. Signing Reason: Signers must explicitly state their role or intent for signing the document by selecting options in the dropdown.
3. Enhanced Audit Trails: Every action ranging from accepting the consent to signing is tracked with precise timestamps, IP addresses, and identity logs, generating a comprehensive Certificate of Completion.
4. Manifested Signature Marks: The final signature box permanently displays the signer’s printed name, the date and time of the signature, and the signing reason directly on the document.

Sending Egnyte Sign GxP Signature Requests

The overall process of sending Egnyte Sign GxP requests is similar to that of non-GxP Egnyte Sign signature requests. However, the signature field is of fixed size and it cannot be modified.

Signing Egnyte Sign GxP Signature Requests

The user experience of signing an Egnyte Sign GxP request differs for an internal or domain user and external or non-domain user.

Internal or Domain User

Internal users with an active account on the Egnyte domain can find the signing link in their email or in the Egnyte Sign dashboard. 

After accepting the consent, the user can fill all the assigned fields. On clicking a signature field, the user can enter their signature and will then be asked to re-authenticate themselves and indicate the signing reason. 

• Email or Username: Domain Email or the username 
• Signing password: Domain password
• Signing reason: Select the reason from the configured options in the dropdown

Once all credentials are properly entered with the signing reason, the user can move forward to fill other fields. This process will repeat for each signature field encountered by the user. The users can submit the document after finishing all the fields.

External or Non-Domain User

An external or non-domain user can find the signing link in their email. The user has to authenticate themselves after clicking on the link and accepting the consent. An Authentication code specific to the user will be shared via email once consent is accepted. 

The Full name entered here will be included in the final rendered signature mark. 

Fill all the required fields and click on the signature field to enter the signature. The users will be required to re-authenticate themselves using the authentication code and indicate the signing reason. 

The Authentication code will be the same as the one mentioned at the start of the signing process. If the page is refreshed, the overall process will reset and a new authentication code will be sent via email.

Fill the rest of the fields once all credentials are entered along with the signing reason. This process will repeat for each signature field encountered by the user. The users can submit the document after finishing all the fields.

Final Signed Copy

When a document is finalized using the Egnyte Sign GxP, the final signed copy will feature an expanded signature box that visibly manifests all the required signature data directly on the page.

Here is a breakdown of what the final signature box will look like, followed by a visual example.

Name: The full printed name of the signer.

Signing Time: The exact timestamp (in UTC) of when the signature was executed.

Signing Reason: The reason for signing the user selected during the signing process.

Unique ID: A visual indicator proving the signature was securely generated by the system.