DMS

Kivo DMS is a validated, cloud-based document management system built for life sciences organizations, including pharmaceutical, medical device, and biologics companies. It is designed for small to midsized teams that need to meet regulatory compliance requirements — including 21 CFR Part 11, GxP, and EU Annex 11 — without the overhead of legacy enterprise systems. The platform supports controlled document management, process automation, project management, corporate document storage, and diligence readiness, all within a single system.

Kivo DMS is part of a broader RegOps platform that includes RIM, QMS, and eTMF modules built natively on the same infrastructure, meaning these functions share data and workflows rather than relying on third-party integrations or patched-together acquisitions.

Controlled Document Management

• Supports Part 11 compliant e-signatures via DocuSign integration
• Role-based access controls allow administrators to grant or revoke access as needed
• Reporting provides visibility into document expiration dates, review windows, and import/export certifications
• Customizable automated alerts notify users when expiration dates are approaching
• Supports templates for SOPs, work instructions, forms, and other recurring document types
• Tracks every action taken on any document, maintaining a complete audit trail
• Version control captures who made changes, when, and why, with the ability to view, compare, or restore earlier versions

Process Automation

• Built on the EDM Reference Model to support structured, compliant document workflows
• Includes automatic naming conventions for documents
• Pre-configured folders and placeholders support structured content organization
• Compliant document workflows are included out of the box and can be customized to match existing organizational processes

Project Management

• Project plans can be tied directly to documents within the system, eliminating the need for external spreadsheets
• Provides real-time reports and views of project progress
• Reduces manual work associated with tracking what is missing, on track, or at risk of missing timelines

Corporate Document Storage

• Provides a secure, compliant mechanism for storing any documents or files requiring added protection
• Part 11 compliant e-signatures are available for corporate documents when needed
• The system is validated from day one and continuously validated with each software release
• Customers receive validation documentation and updated SOPs, removing the need to conduct their own validation

Diligence Readiness

• Designed to support life sciences organizations preparing for asset acquisition or divestiture
• Documents are stored in a compliant, organized structure accessible to auditors and potential buyers
• Supports the review requirements of due diligence processes

Security and Compliance

• Supports GCP/GxP compliance and maintains auditability across the organization at all times
• Quarterly data integrity checks are conducted at no additional cost
• Documents are encrypted in transit and at rest using enterprise-grade infrastructure
• Compliant with 21 CFR Part 11 and EU Annex 11 standards
• SOC 2 certified
• Undergoes third-party penetration testing, real-time monitoring, daily vulnerability scans, and redundant backups
• Software updates are pre-validated and delivered with complete documentation
• Single sign-on (SSO) is supported

Platform Features

• Access to QMS, RIM, eCTD, and eTMF modules is included with no separate integration required
• Role-based, per-user licensing covers full platform access, limited access, and third-party access tiers
• Document linking with aliasing eliminates the need for multi-indexing
• Integrates with Microsoft Office Online and Desktop
• Customizable metadata across features
• Fully browser-based and available for PC and Mac
• No IT infrastructure required; fully cloud-based

Implementation and Support

• Implementation typically takes two to three weeks, compared to six or more months for legacy systems
• Unlimited live training is provided for the duration of the customer relationship, including when new team members are onboarded
• Human support is available five days a week from 6am to 6pm PST, with a stated response time of under five minutes during business hours
• Unlimited support is included with the platform

Kivo DMS is fully cloud-based and requires no internal IT resources to manage. It is designed for life sciences teams that need a validated, audit-ready document management environment with built-in compliance controls, and it can be deployed within weeks. The platform's native integration with Kivo's RIM, QMS, and eTMF modules provides end-to-end visibility across regulatory, quality, and clinical trial workflows from a single system.