21 CFR Part 11 compliance with Zoho Sign

Sending and signing documents from a life science controls enabled Zoho Sign account

Available in Enterprise edition and will be enabled in your account on request

Enabling Life Science controls in Zoho sign

This action can only be performed by administrators. Follow the below steps to enable controls for Life Science in your Zoho Sign account.
  1. From the left navigation pane, hover on Settings > click Account Settings > Controls for life sciences and toggle Controls for life sciences to ON.
  2. A dialog box will be displayed listing all the restrictions and enforcement. Read the instructions, then select the checkbox and click Enable.
  3. The admin can restrict the below features optionally:
    1. Signing documents from mobile browsers
    2. Bulk send
After the controls for life sciences is enabled in your Zoho Sign account, the Controls for Life Sciences v1.0 message can be seen next to the logo and some of the Zoho Sign features will be disabled. Learn more

Sending documents from Controls for life sciences enabled account


  1. At least one Signature or Initial field must be checked as mandatory (as per the sender's requirement).
  2. No prefill signature, initial, or stamp must be present when sending templates for signature.

Signer experience in Controls for life sciences enabled account

  1. The signer must log in to their Zoho Sign account while signing with this method. (If the signer does not have a Zoho Sign account, Zoho Sign will prompt the signer to create one. If the signer has a Zoho Sign account and has not logged in to their account, the system will prompt them to log in.)
  2. Enter the access code received via email or SMS.
  3. Read the legal disclosure and click Agree & Continue.
  4. Fill in the necessary fields and signature wherever necessary.
  5. While filling the first signature/initial field:
    1. The signer will be prompted to enter the signing reason.
    2. Once done, the signer will be prompted to log in to their Zoho Sign account once again.
    3. Once done successfully, the signature/initial will get added to the document.
  6. Once all the fields are filled, click Finish.
  1. If the signing action is re-initiated, the signer must re-authenticate while filling the signature/initial field.
  2. Zoho Sign does not share documents (in PDF) in email or upload the same to the cloud storage providers.

    Zoho CRM Training Programs

    Learn how to use the best tools for sales force automation and better customer engagement from Zoho's implementation specialists.

    Zoho CRM Training
      Redefine the way you work
      with Zoho Workplace

        Zoho DataPrep Personalized Demo

        If you'd like a personalized walk-through of our data preparation tool, please request a demo and we'll be happy to show you how to get the best out of Zoho DataPrep.

        Zoho CRM Training

          Create, share, and deliver

          beautiful slides from anywhere.

          Get Started Now

            Zoho Sign now offers specialized one-on-one training for both administrators and developers.

            BOOK A SESSION

                                    You are currently viewing the help pages of Qntrl’s earlier version. Click here to view our latest version—Qntrl 3.0's help articles.

                                        Manage your brands on social media

                                          Zoho Desk Resources

                                          • Desk Community Learning Series

                                          • Digest

                                          • Functions

                                          • Meetups

                                          • Kbase

                                          • Resources

                                          • Glossary

                                          • Desk Marketplace

                                          • MVP Corner

                                          • Word of the Day

                                            Zoho Marketing Automation

                                              Zoho Sheet Resources


                                                  Zoho Forms Resources

                                                    Secure your business
                                                    communication with Zoho Mail

                                                    Mail on the move with
                                                    Zoho Mail mobile application

                                                      Stay on top of your schedule
                                                      at all times

                                                      Carry your calendar with you
                                                      Anytime, anywhere

                                                            Zoho Sign Resources

                                                              Sign, Paperless!

                                                              Sign and send business documents on the go!

                                                              Get Started Now

                                                                      Zoho TeamInbox Resources

                                                                              Zoho DataPrep Resources

                                                                                Zoho DataPrep Demo

                                                                                Get a personalized demo or POC

                                                                                REGISTER NOW

                                                                                  Design. Discuss. Deliver.

                                                                                  Create visually engaging stories with Zoho Show.

                                                                                  Get Started Now

                                                                                                      • Related Articles

                                                                                                      • Zoho Sign controls for life sciences

                                                                                                        Available in the Enterprise edition and enabled upon request Today, life sciences companies are facing many challenges, which include improving patient/employee experience, reducing costs, and increasing overall efficiency by automating workflows ...
                                                                                                      • 21 CFR Part 11 in Zoho Sign

                                                                                                        Available in Enterprise edition and will be enabled in your account on request What is 21 CFR Part 11? The part 11 of Title 21 of the Code of Federal Regulations establishes the regulations on electronic records and electronic signatures.Records in ...
                                                                                                      • 21 CFR Part 11- Overview

                                                                                                        Available in Enterprise edition and will be enabled in your account on request Zoho Sign now aids businesses and individuals operating in the Food and Drug Administration (FDA)-regulated industries, such as pharmaceutical, biotech, cosmetic, food and ...
                                                                                                      • EU GMP Annex 11 in Zoho Sign

                                                                                                        Available in Enterprise edition and will be enabled in your account on request. European Union (EU) Annex 11 is part of the EudraLex Volume 4 of Good Manufacturing Practice, establishes the criteria for life science industries such as pharmaceutical ...
                                                                                                      • Qualified Electronic Signatures via itsme for EU

                                                                                                        Available only in Enterprise edition and in EU data center This integration allows document signing with Qualified Electronic Signature (QES) and meets the electronic signature specifications laid out by the eIDAS regulation (EU 910/2014). This ...
                                                                                                        Wherever you are is as good as
                                                                                                        your workplace



                                                                                                          Watch comprehensive videos on features and other important topics that will help you master Zoho CRM.


                                                                                                          Download free eBooks and access a range of topics to get deeper insight on successfully using Zoho CRM.


                                                                                                          Sign up for our webinars and learn the Zoho CRM basics, from customization to sales force automation and more.

                                                                                                          CRM Tips

                                                                                                          Make the most of Zoho CRM with these useful tips.

                                                                                                            Zoho Show Resources