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About

Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.

About

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Growing biotech regulatory teams that need compliant document management, quality workflows, submission planning, and clinical trial file control in one validated life sciences platform

Audience

Small and growing businesses in Life Sciences & Healthcare

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$1,800 per month
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Kivo
Founded: 2021
United States
kivo.io

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Alternatives

Alternatives

Propel

Propel

Propel Software
BeeCTD

BeeCTD

Altamira
LifeSphere RIMS

LifeSphere RIMS

ArisGlobal
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Policy Management Features

Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Integrations

Auth0
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
Docusign
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab Duo
Google Cloud Operations Suite
Intercom
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
RegDesk
Zendesk
Zephyr

Integrations

Auth0
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
Docusign
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab Duo
Google Cloud Operations Suite
Intercom
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
RegDesk
Zendesk
Zephyr
Claim Kivo and update features and information
Claim Kivo and update features and information