Kivo, Inc.
Information
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