Compliant Document Management
for Quality Teams

21 CFR Part 11 requires secure electronic records and signature controls, including tamper-proof audit trails, identity verification, and access management. SOP management software helps meet these requirements by capturing who signed what, when, and why, and locking down document access and edits. A compliant system ensures that every document action is traceable and that electronic signatures meet FDA expectations.

Kivo includes built-in, Part 11-compliant eSignatures with options for either DocuSign or audit-ready approvals. Every action taken within Kivo is logged in an uneditable audit trail, and PDF flattening tools help preserve document integrity. These features give teams confidence in the system's compliance and reliability.

Many SOP management platforms support integration with existing tools, helping teams avoid duplication and streamline document creation. Microsoft Office integration allows for native editing of Word documents without breaking version control. DocuSign integration can simplify multi-signature approvals, especially for cross-functional teams.

Kivo integrates natively with Microsoft Office and includes DocuSign support at no additional cost. Teams can draft, edit, and sign SOPs without leaving the system. Kivo also functions as both a standalone DMS and a fully integrated part of the Kivo QMS, allowing flexibility depending on how your organization is structured.

Spreadsheets and file servers depend on manual processes to manage SOP versions. This often results in outdated or duplicate documents floating around, which can lead to compliance issues or audit findings. Versioning mistakes are common in systems that lack centralized control and automatic audit logging.

Kivo eliminates this risk by managing SOPs in a secure, centralized repository. Each document has a unique ID, controlled versioning, and automatic access restrictions. Users only see the current, approved version. Previous versions are archived but locked, ensuring there is never confusion about which SOP to follow.

Yes, modern SOP management systems can automate training assignments when an SOP is revised or released. When configured properly, the system identifies affected users by role or function and sends notifications to complete training on the updated version. This helps ensure staff are always trained on the most current procedures.

Kivo links training directly to the document view in the DMS. Quality teams can assign training to individuals or groups, track completion, and capture eSignatures or acknowledgments. With document-linked training and video support, Kivo makes it easy to keep teams aligned and compliant.

Audit trails capture every action performed on a document, including edits, approvals, views, and signatures. These records must be time-stamped, uneditable, and clearly tied to specific users. A valid audit trail is critical to proving procedural compliance during an FDA or EMA inspection.

Kivo maintains a complete audit history for every SOP and training record. All document actions are tracked in real time and stored in an immutable format. This satisfies regulatory expectations and reduces the time and stress associated with audit prep.

Whether validation is included depends on the vendor. Some systems come fully validated or include validation support with IQ/OQ/PQ protocols. Others require the customer to perform their own validation to ensure the system functions properly in their specific environment.

Kivo provides validation documentation and support tailored to your implementation. This helps customers meet regulatory requirements without taking on the entire validation burden themselves. For teams that need fast, compliant deployment, this is a major benefit.

Effective SOP management systems use built-in tools to track when a document is due for review. These tools send alerts to responsible users, document when reviews are completed, and maintain logs of all decisions. This process helps ensure SOPs are reviewed regularly and remain aligned with current practices.

Kivo supports periodic reviews with intelligent reporting and automated reminders. Quality teams can filter documents by upcoming review dates and assign reviewers directly from the dashboard. Reports can be scheduled and emailed automatically, helping you stay inspection-ready.

A full eQMS ties SOPs to related quality processes such as change control, CAPAs, audits, and training. This creates a closed-loop system where process changes trigger SOP updates and those updates drive training and readiness. It ensures end-to-end traceability and quality alignment.

Kivo’s SOP management is built on its integrated QMS platform. SOPs link directly to training assignments, change control records, and deviation reports. This provides a single source of truth for all quality documentation and eliminates the silos that come with disconnected systems.

Scalable SOP systems are designed to grow with your organization. They support structured metadata, advanced search, and customizable workflows that keep things organized even as document volume increases. Browser-based systems are easier to scale across teams and locations without IT overhead.

Kivo is built to support life sciences companies of all sizes. Whether you're a 10-person startup or a global team managing thousands of SOPs, Kivo offers role-based access, smart reporting, and workflow tools to keep your system clean and compliant. No local installation is needed, and it works on both Mac and PC.