Kivo
Kivo makes simple and affordable document management systems including RIM, eTMF, and QMS. A single license grants access to all our solutions, so you can supercharge cross-functional collaboration without breaking the bank. Fully validated, Part 11 and SOC 2 compliant, Kivo is designed forGxP.
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Kivo Introduction
What is Kivo?
Kivo is the easiest-to-use document and regulatory management solution for life science companies. Kivo's platform includes DMS, RIM, QMS, eTMF and more. All features are included with your subscription - with no separate charges or hidden fees. CFR Part 11 Compliant e-Sign with Docusign | Lifetime Validation | SOC 2 Certified | TMF & EDM Reference Models | GxP Compliant ▶ For Regulatory • Customizable, automatic authoring, review, QC, and approval workflows • Real-time collaboration online or locally in Office 365 • Smart document placeholders, with pre-formatted ICH templates available • Assemble submissions from pre-built submission structures aligned to country guidelines • Create automated tracking spreadsheets for external publishing groups ▶ For Quality • Controlled document and SOP management that meets GxP standards • Training management linked directly to documents in the DMS • Build curricula for teams or individual users with documents, videos, and more • Auto-fill quality forms with metadata • Manage change controls, CAPAs, Deviations, Audits, and Vendors ▶ For Clinical • Workflows mapped to the TMF reference model • Accelerate active trial management, from study start up and beyond • Migrate TMFs into the system in weeks, including recompiled audit trails • Real-time reporting into TMF completeness • Long-term TMF storage at a fraction of the typical cost, with automatic checksums to ensure data integrity • Separate inspector access to help streamline your trial narrative
How to use Kivo?
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Why Choose Kivo?
You gotta pick this if you want an easy-to-use, affordable document and regulatory management system that covers everything from RIM to QMS and eTMF. It’s packed with features that help life science companies stay compliant and collaborate better without breaking the bank.
Kivo Features
Document Management
- ✓Dossier Management
- ✓Tech Files
- ✓Submission Planning
- ✓Archiving
Product Management
- ✓Audit Trails
- ✓Live Dashboards
- ✓Collaborative Authoring
Pricing
Pricing information not available




