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KIVO DMS

Intuitive Document Management for Life Sciences

Control your documents & SOPs, leverage Kivo's native Part-11 eSignature, author and collaborate in Word in real time, and establish GxP compliance across your team.

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The world of drug development has changed

Once dominated by “Big Pharma”, today over 70% of active drug trials are sponsored by emerging biopharma teams — and speed-to-market is more important than ever.

But so is compliance. And safety. And security. Clinical-stage life sciences teams shouldn't have to choose between efficiency and compliance. Kivo offers a better way to work together.

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One Document Management System for Everything

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Compliant, Controlled Document Management

Kivo meets all standard and Part-11 compliance requirements, including flexible e-signatures for your entire team. Secure and managed access is easy to grant or revoke as needed for both internal users and external partners. Customizable reports give instant visibility into document expiration, review windows, workflow status, and more.

For fastest setup, use Kivo's out-of-the-box configuration, or our services team can customize it to match your workflows. Easily add templates for your SOPs, work instructions, forms, and other controlled documents. 

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Process Automation

Built to the EDM Reference Model, Kivo includes simple, smart automation features that make it easy to enforce compliance and SOPs across your organization.

Includes automatic naming conventions, pre-configured folders and placeholders for structured content, compliant document workflows, and more.

Leverage Kivo's standard workflows and automations, or customize them to match your team's way of working. 

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Project Management

Most life science teams are used to tracking projects in spreadsheets outside of their document management system, creating a never-ending cycle of manual work to figure out what is missing, what is on track, and whether you are on pace to meet your timelines.

With Kivo's project management capabilities, you can tie your project plans directly to your documents, giving you real-time reports and views of your project progress. 


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Corporate Documents

Kivo’s DMS provides an efficient, secure, and compliant mechanism for storing any documents or files that require a bit of added protection.​ Part-11 Compliant e-Signatures are built in, should you need them. No clunky workflows, no overhead, just easy-to-use compliance at your fingertips. Kivo's DMS is validated from Day 1, and continuously validated upon each release. You are provided validation documentation and updated SOPs, so you never need to conduct your own validation.

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Diligence Readiness

The majority of Life Science organizations are developing assets that will be acquired or divested. Those assets exist as documents - the documents that prove the efficacy of the drug, device, or therapeutic. Those documents must be stored in a compliant, organized fashion that can be reviewed by auditors and potential buyers - and that's what we've designed with Kivo's DMS.

In fact, many teams use Kivo's included Corporate Documents area as a simple, secure "Data Room" - giving investors and partners access to always up-to-date versions of key docs.

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Best in Class Security & Compliance 

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Kivo was purpose-built for the compliance requirements of the life sciences industry. We enable GCP/GxP, security & auditability across your org at all times, even conducting quarterly data integrity checks (at no cost to you). 

Updates to Kivo's software are pre-validated and delivered with complete documentation. Sponsors around the globe entrust Kivo with their data - and you can too. ​

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Compliance that scales. Costs that don't.

Kivo DMS
  • General Kivo Features
    Unified access to DMS, QMS, RIM & eTMF (No Integration Required)
    Per-User Licensing Tiers for Full Access, with Flexible Read-Only Access for Partners, Training & Part 11 e-Signature
    Document Linking with Aliasing (No Multi-Indexing Required)
    Seamless Integration with Microsoft Office Online or Desktop
    Customizable Metadata Across Features
    Built on EDM Reference Model
  • IT & Security
    Integrated CFR Part 11 Compliant eSignatures
    No IT Required (Fully Cloud Based)
    SOC 2 Type 2 Certified
    Single Sign On
    Fully Browser Based, Available for PC and Mac
  • Support
    Lightning Fast Support During Business Hours (Under 5 Minutes!)
    Unlimited Live Training
    Implement Within Weeks
    Unlimited Support
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Support from Day 1

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Implement Within Weeks

Kivo goes through a rigorous validation process to reduce the burden on your organization and reduce implementation timelines. No more implementations that drag on for months - seriously.

Unlimited Training
Unlimited Training

Receive unlimited training as long as you are a customer. We want to make sure your team is comfortable and able to get work done, so we’ll be there to help every step of the way, even when you bring on new team members.

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Real Human Support

Support is available from a real human being 5 days a week from 6am to 6pm PST. Our current response time during those hours is under 5 minutes (really!)

Compliant Content and Document Management for Life Science

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Kivo Document Management FAQs

What is a Document Management System? 

A Document Management System (DMS) in the pharmaceutical industry is a digital solution designed to manage, store, and track documents related to various processes, including research and development, regulatory compliance, quality assurance, and clinical trials. Key features often include centralized storage, version control, advanced security and compliance capabilities, document collaboration, audit trails, search, and workflow automation. Kivo includes all of those and more!

What does Kivo DMS do?

Kivo DMS provides a central place for your team and third party vendors to collaborate on regulated content and documents that will meet compliance requirements for agencies, auditors, and future investors. It enables you to collaborate in real time, approve documents with Part-11 compliant e-Signatures, manage and report on projects, and keep track of every action taken on any of your documents. 

How does Kivo secure life sciences documents?

Kivo is built from the ground up to meet the stringent security and compliance requirements of life sciences teams. We leverage enterprise-grade infrastructure with 256-bit encryption in transit and at rest. Role-based access controls (RBAC), audit trails, and detailed user permissions give you full control over who can view, edit, or approve content, while maintaining compliance with GxP, 21 CFR Part 11, and EU Annex 11 standards.

Our platform undergoes rigorous third-party penetration testing and is supported by real-time monitoring, daily vulnerability scans, and redundant backups to prevent data loss. In short, Kivo provides the protection your team needs without compromising on usability. For a deep dive into our security, privacy, and compliance protocols, visit our Trust Center.

What is an example of a controlled document?

Controlled documents refer to any document for which the lifecycle (creating, collaborating on, approving, distributing, training, and storing) must be traceable and include an audit trail. Examples of controlled documents could be SOPs, policies, work instructions, protocols, job descriptions, and more. 

How much does Kivo DMS cost?

We pride ourselves on our affordability: visit our pricing page to learn more!

How does a DMS help with FDA compliance?

A modern DMS helps life sciences teams stay compliant with FDA requirements by enforcing strict document controls, traceability, and audit readiness. With Kivo, every document is versioned, access-controlled, and timestamped, ensuring you maintain a complete, compliant history of approvals, edits, and reviews. We support 21 CFR Part 11 electronic signature requirements and validation-ready configurations, making it easier for your team to meet GxP expectations without the overhead of manual processes or disconnected tools.

How does version control work in a document management system?

Version control ensures that your team is always working from the latest approved document, while maintaining a full, unalterable history of previous versions. Kivo tracks every change automatically with metadata that captures who made the change, when it was made, and why. You can view, compare, or restore earlier versions at any time, giving you full transparency and control throughout the document lifecycle. This is essential for audits, CAPAs, and maintaining a strong quality foundation.

How long does it take to implement a DMS?

Kivo implementation typically requires weeks, not months. Many legacy GxP systems typically can take 6 months (or more), because they require extensive consulting, training, custom development, and customer-led validation. Kivo ships ready for CSA Validation and configured out of the box, so implementation is set up rather than construction.

Built for clinical-stage life sciences teams, the interface mirrors the tools your team already uses daily — most users pick it up easily thanks to our included training sessions. And support stays available with under-5-minute response times for the lifetime of your subscription, not just during onboarding and rollout.

Are there cloud-based DMS options for life sciences?

Absolutely, and Kivo is one of them. Our cloud-based DMS is purpose-built for regulated life sciences environments, combining the flexibility and scalability of the cloud with the security and compliance features your team needs. You get real-time access to controlled documents from anywhere, automatic updates, built-in redundancies, and no IT infrastructure to manage. It's the ideal choice for growing teams who need to stay compliant without sacrificing speed or usability.

Can a DMS integrate with other systems like eTMF or QMS?

With Kivo, complex cross-platform integration isn't needed — the DMS, QMS, RIM, and eTMF are all native modules of the same unified Kivo platform. They share one architecture, one validated Part-11 foundation, one access & permissions model, and one audit trail.

Unlike legacy vendors that patch together separately acquired systems, Kivo's fit-for-purpose design eliminates silos, removes duplicate work, and gives your team end-to-end visibility across quality, regulatory, and clinical workflows.

What's the difference between a DMS and an eTMF?

A DMS manages controlled documents across your whole organization — SOPs, policies, work instructions, corporate records. An eTMF manages the specific set of documents that prove a clinical trial was conducted properly, organized to the TMF Reference Model for inspection. Most clinical-stage teams need both. In Kivo they're the same system, so a document authored and approved in the DMS can be filed to the TMF without duplicating it.

Do I have to validate Kivo myself?

No. Kivo uses continuous CSA validation, updated with every release. You receive the full validation package — IQ, OQ, PQ, and UAT documentation — with each update. These validation details and test results are presented to your QA/IT team for easy review and confirmation, with everything stored directly in your production Kivo instance, so your team never has to run its own validation cycle. For most clinical-stage companies this removes the single largest hidden cost of a GxP system.

Can I get my documents out of Kivo if I leave?

Yes. Your data is yours, and Kivo supports GxP-compliant export of your documents with their metadata and audit trails intact. Kivo has compliant tools and processes to migrate documents and data in and out of a wide variety of systems. There's no exit fee and no proprietary format holding your records hostage.

Is SharePoint good enough for GxP document management?

Usually not without significant custom work. SharePoint has no native Part 11 electronic signatures, no built-in validation package, and no GxP-specific audit trail, so teams end up building and validating those controls themselves — then re-validating after every Microsoft update. Kivo provides them out of the box, pre-validated, and integrates with Microsoft Office, so your team can still author and edit documents together in their own MS Word desktop apps.

What makes a document management system 21 CFR Part 11 compliant?

Part 11 requires that electronic records and signatures be as trustworthy as paper ones. In practice a compliant DMS needs validated software, secure and unique user authentication, electronic signatures bound to the record with signer name, date, and meaning, a time-stamped audit trail that can't be altered, enforced version control, and controlled access. Kivo provides all of these natively, with validation documentation supplied for every release.