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    • 2022-06-16 Managing Permissions, Sharing, And Collaborating In Labii ELN & LIMS
    • 2022-06-06 Signing And Witnessing In Labii Electronic Lab Notebook (ELN)
    • 2022-05-09 3 Methods To Create New Entries In Labii Electronic Lab Notebook (ELN)
    • 2022-04-30 How To Document Research Data With Electronic Lab Notebook (ELN) For R&D And Production
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    • 2019-06-02 Labii ELN & LIMS (v4) Released
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    • 2018-12-19 Enhance Your Labii Electronic Laboratory Notebook (ELN) And LIMS
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    • 2018-05-03 Labii Is Releasing A New Version Of Electronic Lab Notebook v3.0
    • 2018-03-22 Using Blockchain Technology In Electronic Lab Notebook (ELN)
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    • 2018-02-28 Labii ELN & LIMS v3 Is On Beta Testing
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    • 2015-09-20 Labii Electronic Lab Notebook Is Now In Beta Testing
    • 2015-09-02 Labii ELN Is On Alpha Testing
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    • 2023-07-23 The Importance of ELN in Academic Research: Lessons from Stanford President's Resignation
    • 2022-08-02 Avoid Research Fraud By Publishing Raw Scientific Data With Labii Electronic Lab Notebook
    • 2022-03-13 What Should You Expect To Pay For An Electronic Lab Notebook
    • 2020-02-06 Labii ELN & LIMS Facilitates Infectious Disease Research
    • 2019-12-13 What Should You Do When Your Scientists Don't Keep Their Lab Notebooks Updated?
    • 2018-10-23 Recent Scientific Fraud In Cardiac Stem Cell Research, How Labii ELN & LIMS Can Help Avoi
    • 2018-10-22 4 Steps To Pick An Electronic Laboratory Notebook (ELN) That’s Perfect For You
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    • 2018-06-21 Alternative Solutions To Top 3 Barriers When Switching From Paper To ELN
    • 2018-02-24 Resolve R&D Bottleneck With Labii ELN & LIMS
    • 2018-01-18 3 Reasons An ELN & LIMS Is Difficult To Meet The Diversity Of Researchers' Interests
    • 2017-08-10 5 Reasons Why You Are Taking Bad Lab Notes
    • 2017-05-15 Here Is Why You Should Never Use Open Source Electronic Lab Notebook
    • 2017-05-04 Increate Competitive Advantage In Biotech With Labii Electronic Lab Notebook
    • 2016-09-16 Labii Helps Dr Haoquan Wu From TTU Health Sciences Center Published A New Article
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    • 2016-06-21 Secrets And Lies Faked Data And Lack Of Transparency Plague Global Drug Manufacturing
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    • 2015-01-22 It Is Time For Labs To Go Digital
  • Product comparisons
    • 2024-10-29 Labii: The Best Affordable Alternative to Benchling for ELN/LIMS
    • 2022-02-02 Here Is Why You Should Choose Labii ELN Over Labfolder
    • 2018-10-04 Labii ELN & LIMS Vs LabWare, Which One Should I Choose?
    • 2018-10-03 Comparative Analysis Of Labii And LabWare In ELN & LIMS
    • 2018-08-30 Comparative Analysis Of Labii ELN & LIMS And Benchling Software Platform
    • 2018-08-30 Labii ELN & LIMS Vs Benchling, Which One Should I Choose?
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    • 2018-07-29 How To Earn Free Credits From Labii ELN & LIMS
    • 2018-02-05 Is An ELN & LIMS Too Expensive For You?
    • 2016-07-31 LIMS Class Medium Deck
    • 2015-12-07 Advice For Those Who Are Beginning The SBIR Grant Proposal Process
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On this page
  • What is Electronic Lab Notebook (ELN)
  • Why signatures are important for ELN
  • Requirement of Signature in ELN
  • Signing and witnessing progress
  • How to sign in Labii ELN
  • Additional signing functions provided by Labii
  • Modify after signing
  • Summary

Was this helpful?

  1. Feature updates

2022-06-06 Signing And Witnessing In Labii Electronic Lab Notebook (ELN)

2022-06-06

Previous2022-06-16 Managing Permissions, Sharing, And Collaborating In Labii ELN & LIMSNext2022-05-09 3 Methods To Create New Entries In Labii Electronic Lab Notebook (ELN)

Last updated 2 years ago

Was this helpful?

What is

An is a software tool used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. are intended to replace paper lab notebooks.

Why signatures are important for

An individual's signature demonstrates his or her agreement to a contract, letter, or other document in a unique and distinctive manner. Signatures are usually shaped like the individual's name, but they can also be any mark or sign, as long as there's a way to verify that the signature belongs to the individual. Electronic signatures are a quick and efficient way to sign documents electronically. Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings.

is the part of Title 21 of the Code of Federal Regulations that sets forth regulations for the United States Food and Drug Administration (FDA) regarding electronic records and electronic signatures (ERES). Records in electronic form created, modified, maintained, archived, retrieved, or transmitted pursuant to agency records requirements fall under Part 11.

By signing a document in , 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.

Signing and witnessing progress

The record must be signed in order. Signing must begin with the first signatory. Upon 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.

  1. In the event of a second signer signing the document, it will further notify the third signer if there is one.

  2. 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.

  3. The process will continue until all signers have signed the document.

    1. Signers button allows you to open a signers tab

    2. Sign button allows you to sign when it is your turn

    3. The Reject button allows you to reject signatures

    4. Sign as author button enables you to add yourself as an author and sign off.

  1. Another option is to add a Signers widget to the section. This widget has the same interface as the signers tab. This allows you to insert the signature into your notebook at the location of your choosing.

A full set of Labii's features makes signing and witnessing in electronic lab notebooks easy and seamless. Below is a list of the functions you can perform, please click the link for more information.

Modify after signing

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.

Summary

Requirement of Signature in

signatures should be unique and be able to capture information about the signer, the record, and the date signed. The signature of the shall be eligible for verification. vendors are expected to provide a mechanism to verify a provided signature as a test to see if it is valid or not.

The Electronic signature of is specifically designed to fulfill this need. To generate a digital signature, we use the information of the signer, the record, and the date of creation. In addition to this, we also allow signers to provide additional remarks and drawings during the signing process. All generated signatures can be checked by Labii internally at any time.

Labii Electronic Signature

Witnessing a person's signature on a legal document is essential to ensuring that the document is valid and enforceable. In , the witnessing and signing processes are identical. If you are the author, you mostly sign the document. If you are a witness, you witness a signed document.

Signing and witnessing progress in Labii

How to sign in

was designed to be user-friendly and provide many ways to facilitate your signing process.

controls all signatures of a record in the signers tab. By clicking on the Signers tab, you can sign and manage all signers and signatures.

When you are documenting your experiment results and are in the Sections or Notes view, you can sign directly from the top buttons.

Additional signing functions provided by

.

In , you can save a default list of signers by clicking "Save as default" 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.

. 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.

For some companies, signing a record in the 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.

Labii enables you to sign and witness experiment records within an to meet FDA 21 CFR part 11 requirements. To learn more, schedule a meeting with Labii representatives (https://call.skd.labii.com) or create an account (https://www.labii.com/signup/) to try it out yourself.

ELN
Electronic Laboratory Notebook
ELN
ELN
Labii
Labii
Labii ELN
Labii ELN
Labii
Labii
Add a new signer
Add signers from default.
Labii's electronic laboratory notebook
Add signers from template
Edit signer information
Change signing order
Remove signer
Set minimum number of signers.
electronic notebook
Signing
Reject
Notify signer
Electronic Lab Notebook (ELN)
Electronic Lab Notebook (ELN)
Electronic Lab Notebook (ELN)
Electronic lab notebooks
ELN
Title 21 CFR Part 11
Electronic Lab Notebook (ELN)