The Regulatory, Clinical, and Quality platform your team (& CFO) will love.
DMS | RIM | QMS | eTMF
Kivo is an affordable document & process management system that helps life sciences teams get work done in one intuitive, compliant workspace.
Powering Innovative Sponsors & Service Partners Worldwide
Part 11 Compliant, Fully 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 (over 800 tests)
- Validation package loaded into your Kivo workspace for each release
- SOP packages updated with each release
DON't take our word for it
Recent Reviews
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."
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."
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."
See what's possible with Kivo today.
"With all that Kivo has to offer, I can't imagine using anything else."
- Senior Manager, Regulatory Strategy
