Related Products
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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.
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About
Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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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
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Audience
Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
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API
Offers API
Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationKivo
Founded: 2021
United States
kivo.io
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Company InformationQualitum
qualitum.ai
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Alternatives |
Alternatives |
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Categories |
Categories |
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Document Management Features
Access Controls
Supported
Archiving & Retention
Supported
Collaboration Tools
Supported
Compliance Tracking
Supported
Document Archiving
Supported
Document Assembly
Supported
Document Capture
Supported
Document Conversion
Supported
Document Delivery
Supported
Document Indexing
Supported
Document Retention
Supported
Electronic Signature
Supported
Email Management
Supported
File Recovery
Supported
File Type Conversion
Supported
Forms Management
Supported
Full Text Search
Supported
Offline Access
Supported
Optical Character Recognition
Not Supported
Print Management
Supported
Version Control
Supported
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Integrations
Docusign
Supported
Gmail
Supported
Jama Connect
Supported
Jira
Supported
Microsoft 365
Supported
Microsoft 365 Copilot
Supported
Microsoft Excel
Supported
Microsoft SharePoint
Supported
Microsoft Word
Supported
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Integrations
Docusign
Not Supported
Gmail
Not Supported
Jama Connect
Not Supported
Jira
Not Supported
Microsoft 365
Not Supported
Microsoft 365 Copilot
Not Supported
Microsoft Excel
Not Supported
Microsoft SharePoint
Not Supported
Microsoft Word
Not Supported
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