The 2026.Q1.6 release includes one new user-facing feature.
A full list of feature requirements can be found at the bottom of this message.
A reminder that you are receiving this message a minimum of 5 business days before the feature release.
21 CFR Part 11 E-Signature
Kivo now supports in-house 21 CFR Part 11-compliant electronic signatures, allowing users to sign documents directly within the platform as part of an approval workflow.
Kivo e-signature supports three signature formats:
In-line — signature block is placed in the document
Appended — signatures appear on a signature page at the end of the document
Audit trail-only — signatures are recorded in the audit trail, but do not appear on the document
Regardless of format, Kivo ensures all signatures are:
Unique to an individual
Authenticated at the time of signing
Inclusive of all required signature elements
Fully auditable
Verifiable for record integrity
Enablement: Feature Flag — disabled on release. Customers will work with Kivo to implement electronic signatures in their organization.
For more information, see the following articles:
Full List of Feature Requirements
ID | Item | Risk | Type | Subsystem Affected | Validation Impact |
KV-4730 | User accepts adopted signature on first e-sign | 4 | New Feature | API/Web | New Test |
KV-4734 | Audit trail records signature acceptance | 4 | New Feature | API/Web | New Test |
KV-4735 | Signature page appended on approval | 3 | New Feature | API/Web | New Test |
KV-4737 | User authentication required before signing | 4 | New Feature | API/Web | New Test |
KV-4745 | Checksum generated after final signature | 4 | New Feature | API/Web | New Test |
KV-4746 | Signing initiated from signature page | 3 | New Feature | API/Web | New Test |
KV-4755 | Workspace Manager enables e-signature in workflow | 3 | New Feature | API/Web | New Test |
KV-4757 | User can initiate e-signature approval step | 3 | New Feature | API/Web | New Test |
KV-5177 | Signed document includes signature manifest | 4 | New Feature | API/Web | New Test |
KV-5196 | Audit trail shows full signature event | 4 | New Feature | API/Web | New Test |
KV-5248 | Embedded in-line signature supported | 3 | New Feature | API/Web | New Test |
KV-5249 | User can configure embedded signature | 3 | New Feature | API/Web | New Test |
KV-5250 | Audit trail-only signature supported | 3 | New Feature | API/Web | New Test |
KV-5255 | Workspace Manager selects allowed e-sign methods | 3 | New Feature | API/Web | New Test |
KV-5256 | User selects e-sign method during approval | 3 | New Feature | API/Web | New Test |
KV-5285 | Audit trail records user authentication | 4 | New Feature | API/Web | New Test |
KV-5286 | Signature audit trail appears on manifest | 4 | New Feature | API/Web | New Test |