What is document control in the life sciences industry?

Document control is the process of managing and maintaining documents to ensure accuracy, compliance, and accessibility throughout their lifecycle. In the life sciences industry, it is critical for meeting regulatory requirements from the FDA, EMA, and other global agencies — ensuring data integrity and minimizing compliance risk during audits. Controlled documents include SOPs, policies, work instructions, protocols, forms, and any other document for which creation, approval, distribution, training, and archiving must be fully traceable.

Why can't life sciences teams use SharePoint, Box, or Egnyte for controlled documents?

SharePoint, Box, and Egnyte are general-purpose file storage and collaboration tools that are not purpose-built for GxP compliance. Achieving Part 11-compliant electronic signatures, audit trails, version locking, and configurable controlled document workflows in these platforms requires extensive custom configuration, third-party integrations, and ongoing validation effort — creating ongoing compliance risk and IT overhead. Kivo provides all of these capabilities out of the box in a pre-validated, life sciences-specific system.

Does Kivo integrate with Microsoft Office for collaborative editing?

Yes. Kivo integrates natively with Microsoft Office for real-time, collaborative document editing in both MS Office desktop applications and MS Office 365 online. Teams can create, edit, review, and e-sign controlled documents through managed Kivo workflows, eliminating the version control gaps and audit trail breaks that occur when using external tools.

How does document control help with FDA compliance?

A purpose-built document control system like Kivo helps life sciences teams stay compliant with FDA 21 CFR Part 11 by enforcing strict document controls, traceability, and audit readiness. Every document is versioned, access-controlled, and timestamped, maintaining a complete, compliant history of all approvals, edits, and reviews. Kivo's validation documentation is provided with every release, ensuring teams always have current evidence of system compliance.

Can Kivo automatically assign training when a controlled document is approved?

Yes. Kivo links training directly to the document view in the DMS. When a new or revised controlled document is approved, training assignments can be made to individuals or groups directly from the document record. Training completion is tracked with e-signature acknowledgment, creating a complete chain from document approval through demonstrated staff competency — in the same system.

KIVO DMS

GxP Compliant Document Control Software - Part 11 e-Signature Included.

Ensure GxP compliance across your organization with 21 CFR Part-11 e-Signatures, access controls, and built-in training workflows.

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Simplify GxP Compliance with Kivo Document Control

A Document Management System designed for Life Sciences

Kivo’s DMS provides an efficient, secure, and compliant mechanism for collaborative authoring, review, approval, and Part 11 Compliant e-Signatures. With Microsoft Office built in, your team can work efficiently (and cost-effectively) while ensuring consistent data integrity.

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CONTROLLED DOCUMENTS

From SOPs to Training to Reporting - All in One Place.

Every time you leave a given system, you create opportunities for error. Version control issues, gaps in the audit trail...you get the idea. Kivo's Document Management System brings everyone together in a controlled way, from authoring all the way to training and beyond.

Benefits of Using Kivo for Controlled Document Management

Part-11 Compliant e-Signatures

With Kivo, you can be confident that your systems and processes are compliant & validated using native Part-11 e-Signatures.

Authoring & Approval Workflows

Real-time collaborative authoring, optional ICH-formatted templates, and real-time reporting on document status.

Real-Time Reporting

Keep track of everything from expiration dates to vendor audits to training logs with Kivo's reporting module. Updated in real time from the DMS, so you always have your finger on the pulse.

Consistent Compliance

From version control to naming conventions to auto-updating audit trails, we ensure documents are handled consistently across the system.

Easily Grant and Manage Access

Easily grant or revoke access for everyone on your team, including view-only access for everyone in your organization, so you are all on the same page.

Training Workflows

Ready to train on your newly approved document? Assign users to training linked directly to your document - and track training completion with real-time reports.

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See how Kivo can help your team reduce manual work and improve compliance.

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GxP Compliant Document Control Software - Part 11 e-Signature Included.

Simplify GxP Compliance with Kivo Document Control

A Document Management System designed for Life Sciences

CONTROLLED DOCUMENTS

From SOPs to Training to Reporting - All in One Place.

Benefits of Using Kivo for Controlled Document Management

Part-11 Compliant e-Signatures

Authoring & Approval Workflows

Real-Time Reporting

Consistent Compliance

Easily Grant and Manage Access

Training Workflows

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