E-Sign Support using ICI BioPharma setting - Revision history

WikiSysop at 14:00, 26 May 2022

2022-05-26T14:00:46Z

WikiSysop at 13:59, 26 May 2022

2022-05-26T13:59:57Z

WikiSysop at 13:57, 26 May 2022

2022-05-26T13:57:50Z

WikiSysop at 13:51, 26 May 2022

2022-05-26T13:51:17Z

WikiSysop at 13:04, 26 May 2022

2022-05-26T13:04:24Z

WikiSysop at 12:54, 26 May 2022

2022-05-26T12:54:37Z

Show changes

WikiSysop: Created page with " = E-Sign Support using ICI BioPharma setting = ICI Platform now supports the Life Science industry documents that need to comply with 21 CFR Part 11 (for US FDA) or Annex 11..."

2022-05-23T01:18:43Z

Created page with " = E-Sign Support using ICI BioPharma setting = ICI Platform now supports the Life Science industry documents that need to comply with 21 CFR Part 11 (for US FDA) or Annex 11..."

New page

= E-Sign Support using ICI BioPharma setting =

ICI Platform now supports the Life Science industry documents that need to comply with 21 CFR Part 11 (for US FDA) or Annex 11 (for EU) regulatory compliance.

This feature allows integration with DocuSign Part 11 module and Adobe Sign Bio-Pharma setting to get electronically signed approvals for such agreements.

== Overview ==

The US FDA or EU mandate regulatory compliance for the life sciences and healthcare organizations:

*21 Code of Federal Regulations, Part 11 (21 CFR Part 11) for US FDA (ext links)
*Annex 11 for EU
<div class="note-box">'''Note: '''In the ICI framework, 21 CFR Part 11 and Annex 11, are referred to as BioPharma settings. It is supported for Adobe Sign and DocuSign only.</div>
This is to ensure that the systems used to create, update, transfer, or manage electronic data are designed to ensure the authenticity and reliability of that data.

Adobe Sign and DocuSign provide an option of BioPharma setting to enforce this regulatory compliance. This setting is applied as follows:

*Adobe: applied at the user/group level
*DocuSign: applied at an account level

{| border="1" cellpadding="0" cellspacing="0"
|-
| style="width:671px;" |
'''Note:''' There can be some groups in the life sciences sector that do not require biopharma compliance to get approvals.

|}

ICI platform has an added functionality to support Adobe Sign/DocuSign authentications that facilitates the following:

*Sending agreements for approvals
*Updating agreement status
*Sending notifications to the approvers
*Eliminating dependency on manual signatures

The further sections in this document explain using Bio-Pharma setting in ICI Platform.

@@ Line 38: / Line 38: @@
 *Bio-Pharma is supported with and without a console for Adobe Sign and DocuSign.
 *BioPharma enabled Agreements do not support Hybrid and Manual signature types.
-=  =
 = Using the BioPharma setting =

@@ Line 38: / Line 38: @@
 *Bio-Pharma is supported with and without a console for Adobe Sign and DocuSign.
 *BioPharma enabled Agreements do not support Hybrid and Manual signature types.
+=  =
 = Using the BioPharma setting =

@@ Line 83: / Line 83: @@
 .&nbsp; While creating an agreement a provider with BioPharma settings enabled needs to be selected from “eSignature Provider” dropdown list.
+<div class="image-green-border">[[File:ESignature Provider dropdown.png|700px|ESignature Provider dropdown.png]]</div>
 [[File:ESignature Provider dropdown.png|700px|ESignature Provider dropdown.png]]
-−
 &nbsp;
+<div class="image-green-border">[[File:ESignature Provider dropdown docusign.png|700px|ESignature Provider dropdown docusign.png]]</div>
 [[File:ESignature Provider dropdown docusign.png|700px|ESignature Provider dropdown docusign.png]]
-−
 == With User settings ==
@@ Line 163: / Line 159: @@
 i.&nbsp;&nbsp; &nbsp;Hybrid Signature type is not supported in BioPharma enabled Agreements. This validation is triggered on all create/edit actions of the agreement.
+<div class="image-green-border">[[File:Validation1.png|center|350px|Validation1.png]]</div>
 [[File:Validation1.png|center|350px|Validation1.png]]
-−
 ii.&nbsp;&nbsp; &nbsp;Invalid or null value phone number is validated when “Phone Authentication” is selected as the preferred mode for signatory authentication. This validation will be triggered on “Send for Approval” and while sending the agreement for electronic signature.
+<div class="image-green-border">[[File:Validation2.png|center|350px|Validation2.png]]</div>
 [[File:Validation2.png|center|350px|Validation2.png]]
-−
 iii.&nbsp;&nbsp; &nbsp;Null value signature blocks are validated only in the case of DocuSign, as signature blocks are mandatory fields in agreement documents for CFR compliance. This validation is triggered on “Send for Approval” and while sending the agreement for electronic signature.
+<div class="image-green-border">[[File:Validation3.png|center|350px|Validation3.png]]</div>
 [[File:Validation3.png|center|350px|Validation3.png]]
-−
 &nbsp; &nbsp; &nbsp; iv.&nbsp;&nbsp; &nbsp;Get necessary authentications. The Signer must authenticate the Agreement using the preferred mode of authentication before opening the agreement as well as before submitting the agreement with an electronic signature.
 Following are some images provided for your reference:
+<div class="image-green-border">[[File:Adobe Sign Authentication Page.png|center|450px|Adobe Sign Authentication Page.png]]</div> <p style="text-align: center;">'''Adobe Sign Authentication Page'''</p> <div class="image-green-border">[[File:Phone Authentication Page.png|center|Phone Authentication Page.png]]</div> <p style="text-align: center;">'''Phone Authentication Page'''</p>
 [[File:Adobe Sign Authentication Page.png|center|450px|Adobe Sign Authentication Page.png]]
 <p style="text-align: center;">'''Adobe Sign Authentication Page'''</p>
 [[File:Phone Authentication Page.png|center|Phone Authentication Page.png]]
 <p style="text-align: center;">'''Phone Authentication Page'''</p>
 = Limitations =
 In the case of DocuSign, users in “Cc” must have a DocuSign account along with Signers for sending the agreement successfully for signature.<br/> For more details about limitations on using CFR Part 11 module at an account level, refer to&nbsp;[https://support.docusign.com/s/articles/DocuSign-CFR-Part-11-Module-Features-and-Functions-Not-Available https://support.docusign.com/s/articles/DocuSign-CFR-Part-11-Module-Features-and-Functions-Not-Available].

@@ Line 162: / Line 162: @@
 .&nbsp; Validate the configurations before sending the Agreement for signatures. The validations include the following:
-&nbsp; &nbsp; &nbsp; i.&nbsp;&nbsp; &nbsp;Hybrid Signature type is not supported in BioPharma enabled Agreements. This validation is triggered on all create/edit actions of the agreement.
+i.&nbsp;&nbsp; &nbsp;Hybrid Signature type is not supported in BioPharma enabled Agreements. This validation is triggered on all create/edit actions of the agreement.
 [[File:Validation1.png|center|350px|Validation1.png]]
-&nbsp; &nbsp; &nbsp; ii.&nbsp;&nbsp; &nbsp;Invalid or null value phone number is validated when “Phone Authentication” is selected as the preferred mode for signatory authentication. This validation will be triggered on “Send for Approval” and while sending the agreement for electronic signature.
+ii.&nbsp;&nbsp; &nbsp;Invalid or null value phone number is validated when “Phone Authentication” is selected as the preferred mode for signatory authentication. This validation will be triggered on “Send for Approval” and while sending the agreement for electronic signature.
 [[File:Validation2.png|center|350px|Validation2.png]]
-&nbsp; &nbsp; &nbsp; iii.&nbsp;&nbsp; &nbsp;Null value signature blocks are validated only in the case of DocuSign, as signature blocks are mandatory fields in agreement documents for CFR compliance. This validation is triggered on “Send for Approval” and while sending the agreement for electronic signature.
+iii.&nbsp;&nbsp; &nbsp;Null value signature blocks are validated only in the case of DocuSign, as signature blocks are mandatory fields in agreement documents for CFR compliance. This validation is triggered on “Send for Approval” and while sending the agreement for electronic signature.
 [[File:Validation3.png|center|350px|Validation3.png]]
@@ Line 179: / Line 179: @@
 [[File:Adobe Sign Authentication Page.png|center|450px|Adobe Sign Authentication Page.png]]
+<p style="text-align: center;">'''Adobe Sign Authentication Page'''</p>
-==== Adobe Sign Authentication Page ====
-−
-&nbsp;
-−
 [[File:Phone Authentication Page.png|center|Phone Authentication Page.png]]
+<p style="text-align: center;">'''Phone Authentication Page'''</p>
-==== Phone Authentication Page ====
-−
 = Limitations =
 In the case of DocuSign, users in “Cc” must have a DocuSign account along with Signers for sending the agreement successfully for signature.<br/> For more details about limitations on using CFR Part 11 module at an account level, refer to&nbsp;[https://support.docusign.com/s/articles/DocuSign-CFR-Part-11-Module-Features-and-Functions-Not-Available https://support.docusign.com/s/articles/DocuSign-CFR-Part-11-Module-Features-and-Functions-Not-Available].

@@ Line 93: / Line 93: @@
 You can configure the authentication method in User settings. For instance, if “First Approver” is an existing user, then in the “Edit User” page, the Authentication method should be selected as “eSign Authentication”.
+<div class="image-green-border">[[File:With User Setting.png|700px|With User Setting.png]]</div>
 [[File:With User Setting.png|700px|With User Setting.png]]
-−
 == With Contract settings ==
 .&nbsp; You can configure the authentication method in the Contract Type settings. For instance, if “Automation Basic Agreement” is an existing contract type, the Authentication method for both internal and external signatory is selected as “ESign Authentication”.
+<div class="image-green-border">[[File:With Contract Type.png|700px|With Contract Type.png]]</div>
 [[File:With Contract Type.png|700px|With Contract Type.png]]
-−
 .&nbsp; Create an Agreement using BioPharma enabled eSign account.
+<div class="image-green-border">[[File:Contract Type Esign Provider.png|700px|Contract Type Esign Provider.png]]<br/> &nbsp;<br/> For instance, in the Agreement:</div>
-[[File:Create Agreement.png|700px|Create Agreement.png]]
-−
-&nbsp;
-−
 [[File:Contract Type Esign Provider.png|700px|Contract Type Esign Provider.png]]<br/> &nbsp;<br/> For instance, in the Agreement:
-−
 *Add “First Approver” and “Second Approver” as external signatories.
 *Add “Third Approver” as an internal signatory.