To ensure a higher standard of research and to comply with the FDA21 CFR/11 code of federal regulation, completed experiments, protocols, documents, and SOPs can be signed, witnessed, or rejected.
This is a two-step procedure involving two separate group members:
a. Signing an entry – The owner, account admins, and experiment editors may all sign.
b. Witnessing/rejecting an entry – Only authorized members can witness or reject an entry.
Witnessing privileges are assigned to members by the account owner; see Account roles and privileges. If a specific signature flow is applied to a project, only members who were defined in that flow will have the option to witness project-related experiments (even if their role does not include the 'Can witness' privilege). See more information about signature flows.
When a document is signed, users with witnessing privileges can receive a notification if they were mentioned in the signing window. They can then review the entry and witness/reject it. Comments can be added in this section.
How to Sign, Witness, and Reject an entry
1. After completing an entry (experiment/protocol/document/SOP) it can be signed by clicking Sign at the top right side of the document.
2. A pop-up window will open with an option to add a comment and mention a specific user with witnessing privileges. Click on the Sign button at the bottom of the window.
3. A user verification window will appear. Enter your username and password and click on Confirm (* if your account has SSO implemented, there is no need to enter email and password, only click on confirm)
Note: Signed documents cannot be edited; however, comments can still be written in the discussion thread. The signature can be reverted, making the document editable again.
An indication with the signer's name and time of signing will appear in green under the experiment name, and a notice will be sent to the account's owner and all members with witnessing privileges.
4. After an entry has been signed, a user with witnessing privileges has 2 options:
Witness the entry – locking it permanently.
Reject the entry – reverting the signature and making the entry editable again.
5. Enter your username and password to complete the witnessing/rejecting process and click on Confirm.
After an entry has been witnessed, an indication with the witness’s name and time of witnessing will appear in orange under the entry title.
Click here for an instructional video explaining this feature.