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
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
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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.
