Overview
Kivo’s native Part 11 e-signature platform is designed to deliver secure, compliant, and fully traceable electronic signatures, directly within the application.
Built on a validated system architecture and aligned with 21 CFR Part 11 and EU Annex 11, Kivo ensures that every signature, record, and action is:
Authenticated
Traceable
Tamper-evident
Audit-ready
This article explains how Kivo’s approach supports regulatory compliance while improving system reliability, user confidence, and operational efficiency.
Why Part 11 E-Signatures Matter
We understand that our customers working under regulated environments require 21 CFR Part 11–compliant electronic signatures—they are not optional, but foundational.
They ensure that:
Electronic records are trustworthy and reliable
Signatures are attributable to specific individuals
Actions are fully traceable and audit-ready
These requirements sit at the core of quality, compliance, and patient safety. Every approval, every document, and every signature must stand up to scrutiny.
The Challenge with Traditional Integrations
For many years, integrations like DocuSign helped meet these requirements and provided a path to compliance within Kivo.
However, that experience often came with trade-offs:
Authentication handoff issues between systems
Delays or failures in syncing signature status
Fragmented audit trails across platforms
A user experience that felt disconnected from the document lifecycle
While compliant, these workflows introduced complexity and risk, particularly in environments where accuracy and traceability are critical.
Building a Better, More Reliable Solution
To address these challenges, Kivo set out to build a native Part 11 e-signature platform that eliminates external dependencies while maintaining the highest standard of compliance.
It was essential to us that this new solution be:
Fully aligned with 21 CFR Part 11 and Annex 11 expectations
Validated and testable
Secure by design
Audit-ready at every step
An improved end-user experience and efficiency
The result is a platform that not only simplifies the signing experience but does so without compromising compliance, in fact, strengthening it.
How Kivo Delivers Part 11 Compliance
Kivo’s native e-signature platform is built around the core principles defined in Part 11 and Annex 11. Below are the key components and how Kivo meets each requirement.
System Validation and Reliability
Regulations require that systems be validated to ensure consistent and reliable performance.
Kivo achieves this through:
Risk-based validation processes for every release
Documented requirements and traceability to testing
Controlled change management
This ensures the system behaves predictably and can detect invalid or altered records.
Secure Access and User Authentication
Part 11 requires strict control over who can access and sign records.
Kivo enforces this through:
Unique user identities and credentials
Role-based access controls
Authentication required at the time of signature
This guarantees that every signature is uniquely attributable to a verified individual.
Electronic Signature Integrity
Electronic signatures must be secure, unique, and legally binding.
Kivo ensures that:
Signatures are permanently linked to their records
They cannot be copied, transferred, or reused
Each signature includes:
Signer name
Date and time
Meaning of the signature (e.g., approval)
This creates a complete and compliant signature record.
Audit Trails and Traceability
A core requirement of Part 11 is a secure, time-stamped audit trail.
Kivo provides:
Automatic tracking of all document actions
Full visibility into who did what and when
Immutable history (no overwriting of records)
Exportable logs for inspections and audits
This ensures complete transparency across the document lifecycle.
Data Integrity, Security, and Retention
Regulations require that records remain accurate, protected, and accessible over time.
Kivo supports this with:
Encryption of data in transit and at rest
Robust backup and disaster recovery processes
Long-term data retention and accessibility
This ensures that records remain secure, intact, and retrievable throughout their lifecycle.
Workflow and System Controls
Part 11 emphasizes controlled processes and sequencing.
Kivo enforces this through:
Structured workflows with defined approval steps
Controlled transitions between lifecycle stages
Permission-based actions aligned to user roles
This reduces risk and ensures consistent execution of regulated processes.
A Better Way to Capture Signatures
Kivo’s native Part 11 e-signature platform was built with a clear goal:
Deliver a signing experience that is both more efficient and more reliable, without sacrificing compliance.
By removing external dependencies and embedding signatures directly into the platform, Kivo provides:
A seamless, in-app signing experience
Real-time status updates with no sync delays
A single, unified audit trail
Reduced risk of authentication and integration failures
Most importantly, this approach delivers equal or greater compliance compared to traditional third-party solutions while significantly improving usability.
Contact [email protected] if you have any additional questions or are ready to enable the new signature fuctionality.