GxP Compliance for the Agentic Era of Life Sciences

Kivo is an affordable document & process management system that helps life sciences teams get work done in one intuitive, compliant workspace.

Purpose-Built for Scaling Pharmaceutical and Life Science Teams

Kivo offers a shared workspace where every function can manage their documents, programs and even vendors in a way that's intuitive, efficient and - of course - compliant. And our all-inclusive pricing means that everyone has access, without breaking the bank.

Introducing Headless GxP

Headless GxP is the architecture for regulated R&D in an agentic world — where any tool, any model, and any workflow can plug into a compliant system of record without living inside it.

Recent Reviews

Kristi N.

VP of Regulatory Affairs

"Kivo was really fast to set up training, and then because the system is so user-friendly, it just didn’t take that much time to get people up to speed. Normally the learning curve with a system like this is quite steep, but Kivo is so intuitive we can quickly get people oriented and off to the races."

Brian A.

Senior Manager, Regulatory Affairs

"Kivo is extremely user friendly, which has allowed implementation of the RIM system seamlessly throughout our company. The Kivo team has been great in walking us through the various questions we have and implementing feedback to better enhance our experience."

Veronique V.

Quality Assurance Manager

"We're very happy to have all our documents stored in the same place. It's efficient to have a system where the review of a doc can be done simultaneously by several reviewers. The Kivo team is always ready to help and always listen to customer needs. Really appreciated."

Tara G

CEO & Principal Consultant

"Kivo is a QMS & RIMs game changer. It competes strongly against its Goliath peers. From onboarding to troubleshooting, their team has been a reliable partner at every step."

Marissa B.

Senior Manager, Regulatory Affairs

"I have been using Kivo daily for over 2 years to manage 15+ drug development programs. It was extremely easy to learn and very intuitive for a regulatory affairs professional. Kivo makes the process incredibly easy."

Seppe G.

Director of Regulatory Affairs and Quality Assurance

"The intuitive on-line interface has been adapted quickly by the entire development team allowing both the CMC experts as well as the clinical team to seamlessly integrate internal documents as well as controlled documents from external parties."

Document Management

Part 11 Compliant, Validated Document & Content Management System

  • Collaborative editing with Microsoft Office, online or locally
  • Utilize built-in Part 11 compliant electronic signatures
  • Automate and enforce workflows that match your processes
  • Set access rights based on user roles/permissions
  • Query data across Cabinets with Search

#1 Regulatory Management System for Life Sciences

  • Complete RIM System for the entire submission lifecycle
  • Real-time collaboration in Word
  • Correspondence and commitment tracking
  • Publishing export & eCTD viewer
  • Part-11 Compliant e-Signatures
  • Customizable automated workflows

A Quality Foundation for Growing Teams

  • SOP authoring, approval, and training workflows
  • Training curriculum builder
  • Real-time reporting
  • Vendor tracking & audits
  • Quality event management
  • User permissions & document access by user role
  • Naming conventions by document type

eTMF, TMF Migration, and Active Trial Management

  • Active trial management from study startup to close out
  • Compliant & affordable TMF long-term storage
  • Easy data migration both in and out of the system - no lock-in
  • Always inspection ready, including quarterly data integrity checks
  • TMF completeness reporting

Security & Trust

Security and data integrity is at the heart of what we do. We help our customers achieve compliance, and that starts with us.

Security & Architecture

  • Single Sign On (SSO), Multi-Factor Authentication (MFA) Ready​
  • User Attack Vector Protection: Bot Detection, IP Throttling, Brute-force Protection, Breached Password Detection​
  • All data uses 256-bit encryption in transit and at rest​
  • Multi-continent data failover and auto-scaling​
  • Highly granular user permission model to control access including a secure document viewer that prevents downloading, printing, or copying text from documents​

Validation Approach

  • Qualification, testing, and validation approaches aligned with software and GCP best practices
  • Complete OQ in a validation environment conducted prior to each release, screenshots provided
  • UAT in production as part of each release that includes major process and performance considerations
  • Validation package loaded into your Kivo workspace for each release
  • SOP packages updated with each release

Kivo FAQs

What is Kivo?
Kivo is a compliant document, content, and process management platform specifically tailored to the life science industry. Kivo offers Document Management (DMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM) and Quality Management (QMS) solutions, as well as ICH templates. Kivo's customers include sponsors of pharmaceutical, biologic, or other therapeutic products, medical device products, as well as consultants and service partners.

What is Document Management?
Document management is the systematic control of documents and records throughout their lifecycle, from creation and storage to sharing and eventual archiving or disposal. It involves processes and tools designed to organize, secure, and manage documents efficiently. For the life sciences industry, document management also includes adhering to regulations from regulatory agencies around the world, such as Part-11 Compliance in the US and Annex-11 in the EU. A document management system (or DMS) specifically designed for the pharmaceutical and medical device industries can significantly improve your ability to meet these compliance requirements.

Is Kivo a SaaS product?
Yes. Kivo is a Software-as-a-Service - meaning we charge a subscription fee for access to the platform. The services we provide include implementation, setup, maintenance, continuous validation, training, and more. Kivo is stored entirely in the cloud, meaning there is no on-premises component. Kivo requires no IT to deploy.

Can I choose the Kivo applications I need?
Yes you can, but all of our applications (we call them "modules") are included in your license. This means you get access to Regulatory (RIM), Clinical (eTMF), Quality (QMS), and Document Management (DMS) for the same price. However, if you already have systems in place for some of these functions, you can absolutely keep them and only leverage Kivo for what you need! Additional modules can be turned on at any time.

Does Kivo work on Macs?
Yes! Kivo is fully browser-based, and works seamlessly with either PCs or Macs.

What does Kivo cost?
We pride ourselves on our affordability. Kivo is fully compliant with CFR 21 Part-11. We offer e-signatures with Docusign, embedded directly in the platform - meaning you do NOT need a separate Docusign license.