Sign and witness of a record
By signing a document in Electronic Lab Notebook (ELN), you certify that the record you generated or witnessed is accurate to the best of your knowledge. A signed document ensures that the data generated meets regulatory requirements, such as FDA 21 CFR part 11 and others can repeat the results based on the signed document. A lab notebook with signatures represents a legally valid, permanently written record of a lab’s research, which can be used in a court of law in patent investigations.
The signers tab enables ELN users to manage a list of signers with various roles (Authors, Co-Authors, Witnesses), to sign and to witness an entry. It is an improvement over the previous Signature widget.
The Signers tab is one of the most commonly used tabs, and it can be opened under the Overview, Sections, and Notes tabs.
- Open the Signers tab on the Overview tab. When a record is open, under the Overview tab, click Signers to open the signers tab.
- Open the Signers tab on the Sections tab. To open the Signers tab, click the Signers button on top.
- Open the Signers tab on the Notes tab. To open the Signers tab, click the Signers button on top.
With this tab, you can manage a list of signers who need to sign the record/entry.
To add a signer, click "+Signers". This will display a form.
- 1.Choose a signer from the Signer dropdown list.
- In the dropdown list, only users with at least view permission will appear. If the signer you want to add does not appear in the list, please go to the project of the record and add the user to the members.
- By default, 10 users will be displayed. When there are more than 10 users, use the search function to find the signer you are trying to add.
- 2.Select a role from the dropdown. Currently, Labii supports the roles of "Author", "Co-author", "Witness", "Inspector", "Manager", "Signer", "Submitter", and "Recipient". Please contact [email protected] if you would like to have additional roles added.
- 3.Click Submit button
In Labii's electronic laboratory notebook, you can save a default list of signers by clicking "Save as default signers" to avoid adding the same list of signers again and again. The default list of signers will be added to the newly created record once saved. Each table can have a customized list of default signers.
In the absence of any signers, clicking "Save as default signers" will remove the default list of signers.
For existing records without any signers, you can also use "Load default signers" to load the default signers list.
When the record is created from a template, the signers will be copied and you will not need to enter them again for the new record.
You can change the role of a signer by hovering over the signer and clicking the "
" icon. From the dropdown, choose a role and click submit.
All other fields cannot be changed.
It is possible to update the signing order if no one has signed the document. To change the order, click on the "
" icon, and drag the signer to the expected order and release.
To remove a signer, click on the "Remove" button. You can only remove unsigned signers.
Signed users cannot be removed.
For some companies, signing a record in the electronic notebook required at least two signers, one as author and the other as witness. A minimum number of signers for a table can be set according to your company's policy. Unless the number of added signers reaches a minimum number of signers, the first signer will not be able to sign the document.
You will be instructed on how many more signers need to be added.
Click on "Set minimum signers" to change the minimum number of signers. Changing the value can also be done in Settings -> Tables -> Click table name -> minimum_number_of_signers. This can only be done by administrators.
You can search signers by typing a keyword into the search bar in the signer list view, and then clicking Search. The search results can always be cleared by clicking the Clear button.
With the Filter function, you can limit the number of signers displayed. You can do that by clicking All signers and then selecting a filter from the dropdown. Here are a list of filters:
- All signers. Filter to display all signers.
- Signed signers. Filter to display the signers already signed.
- Unsigned signers. Filter to display the signers need to sign.
In Labii, the signing and witnessing processes are identical. If you are the author, you mainly sign the document. As a witness, you are witnessing a signed document.
The signers must sign the record in order. The first signer must sign first. After signing, the record will be locked from editing and the second signer will be notified to sign. The second signer can either continue to sign or reject the signature.
- In the event of a second signer signing the document, it will further notify the third signer if there is one.
- If the second signer rejects the signature, the record will revert to editing mode. The first signer will then be notified to update the record.
- The process will continue until all signers have signed the document.
When it is your turn to sign, you will see a "Sign" button under your name. To sign, click the "Sign" button.
- 1.Please add a comment if you wish.
- 2.Enter your login password. Your login password is used to verify your identity. If you use SSO to login, you can reset/generate your Labii password by clicking the Forgot Password link on the Login page.
- 3.Sign your name.
- 4.Click on Submit to sign. By signing, you certify that the record is accurate to the best of your knowledge. After signing, the document cannot be changed or deleted.
- 5.The next signer will be notified after signing.
If it is not your turn to sign, you will see a message that says "
Waiting for xxx to sign!". A signer can also be notified to sign by clicking the "Notify Signer" button.
Click the "Reject" button if you don't approve the document after it has been signed by the authors.
You will be required to enter the reason for your rejection and the login password to verify your identity.
Upon rejection, the record will revert to editing mode. Your comment will be sent to the signed signers.
At the Section and Notes tab, you can also sign the record.
- When it is your turn to sign, you will see a sign button at the top of the Sections/Notes tab. Click "Sign" to sign.
- If you are the next witness, you should see a sign and reject button on the Section/Notes tab. Click "Sign" to sign, and "Reject" to reject.
If there are no signers added, and there is no limit to the minimum number of signers, the Sign button on the Sections and Notes tab will display as
Sign as author. Clicking this button creates a signer in your name and signs the document simultaneously.
Additionally, Labii's Signers widget enables you to sign directly inside a document. It displays the same content as the Signers tab. The widget replaces the previous Signatures widget.
Once a document is signed, it cannot be changed. Whenever there is a need for changes, you should have the next signer reject the signature so that the record will return to the editing mode.
If all signers have signed, you can add a new signer and have that person reject the signatures.
All signers must resign the document after all changes have been made.
Labii documents each sign-off and rejection, ensuring the change of data meets the regulatory requirements.