KIVO QMS
Quality Management for Growing Pharma Teams
Control your documents, manage quality activities & vendors, and keep track of training with Kivo's validated, Part-11 compliant Quality Management System, designed for pharmaceutical teams.
Confidently Manage Quality Events & Documents
Controlled Documents
Kivo’s Quality Management System is built on our Part 11-compliant Document Management Platform, which gives pharmaceutical teams the structure and flexibility they need to stay compliant and audit-ready:
- Role-based permissions and document access control, ensuring only the right users can view, edit, or approve.
- Automated naming conventions by document type to enforce consistency across the organization.
- Template-driven document creation to standardize formatting and reduce errors.
- Customizable workflows for authoring, editing, review, and approval, tailored to your internal QA processes.
- Support for both audit-ready “simple approval” workflows and integrated DocuSign eSignatures for full Part 11 compliance.
Quality teams also use Kivo’s built-in Reporting and Dashboards to track document status, effective dates, review cycles, and upcoming renewals, making it easier to manage your document lifecycle without falling behind.
Quality Events
Kivo gives pharmaceutical quality teams a centralized, compliant platform to create, manage, and track every type of GxP-relevant quality event with ease. With configurable forms, purpose-built templates, and automated workflows, Kivo helps standardize and simplify the way you manage:
- Incidents and product complaints
- Deviations and non-conformances
- Risk evaluations and mitigation tracking
- Change control activities
- CAPA (Corrective and Preventive Action) workflows
Each event type is fully configurable to align with your SOPs, regulatory requirements, and internal review cycles. Kivo’s platform also supports automated document generation from approved templates.
Track everything in real time with custom dashboards, visual reports, and automated notifications, helping your team stay on top of due dates, approvals, and audit readiness at every step.
Audits
Kivo empowers pharmaceutical teams to simplify, accelerate, and confidently manage internal, vendor, and partner audits. Key features include:
- A dedicated ‘Inspector’ user role for secure, remote audits and due diligence reviews
- A centralized Vendor Management area with pre-built templates for audit forms, documentation, and planning
- The ability to easily link internal audits to other quality events like CAPAs, deviations, or risk assessments
- Full audit trail visibility and access control, ensuring all activities are documented and inspection-ready
With Kivo, pharmaceutical organizations can move faster, reduce manual prep work, and always be ready for regulatory inspections or partner audits.
Vendor & Supplier Management
Kivo's QMS provides a centralized, audit-ready system for managing all aspects of your vendor and supplier relationships, helping pharmaceutical companies meet evolving regulatory and quality expectations.
- Create, manage, and store all vendor qualification documents, questionnaires, and audit records in one place
- Track key supplier data, including approval status, risk classification, renewal dates, and performance history
- Plan and monitor ongoing vendor oversight using built-in project and activity management tools
- Generate real-time dashboards and automated reports to maintain visibility across your entire supplier network
Kivo ensures every vendor relationship is documented, traceable, and aligned with your compliance and quality standards. Stay in control of your supply chain and ready for inspection at all times.
Training Management
Kivo QMS makes it easy for pharmaceutical organizations to build and maintain a fully traceable, inspection-ready training program, integrated directly into your broader quality system.
- Build training courses using SOPs, policies, videos, and presentations already stored in your QMS
- Assign training by role, department, or individual, ensuring the right people are trained on the right content
- Use our Training Reports to track and manage training compliance by course, element, and employee.
- Link to external learning content or upload completed training records for centralized storage and future audits
Kivo offers teams a simple and compliant way to manage training on SOPs, corporate policies & more, all as part of our audit-ready QMS.
Dedicated Support from Day #1
Implement Within Weeks
Kivo’s pre-validated software and streamlined onboarding process mean you can implement a fully compliant quality management system in pharma in just weeks. Our rigorous validation reduces the burden on your team, eliminating the need for months-long configurations and custom setups. No drawn-out timelines. No unnecessary complexity. Just fast, compliant deployment—seriously.
Unlimited Training
With Kivo, you get unlimited training for your team, no caps, no hidden fees. Whether you're onboarding new team members or exploring new features, our team is here to support you every step of the way. Because a great pharma QMS isn’t just about software. It’s about empowering your team to use it confidently.
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Real Human Support
Get fast, reliable help from a real human without needing to mess with bots, reroutes, or endless wait times. Our support team is available Monday to Friday, 6am–6pm PST, with average response times under 5 minutes. Responsive, knowledgeable support is part of what makes Kivo a trusted QMS for pharma teams.