QMS

Kivo QMS is a cloud-based Quality Management System built for life sciences organizations, including pharmaceutical, biotechnology, and medical device teams. It provides a pre-validated, 21 CFR Part 11 compliant environment for managing quality documents, quality events, vendor relationships, audits, and training programs — all within a single platform.

The system is built on Kivo's Part 11 compliant Document Management Platform and is designed to support growing drug development teams that need to standardize quality operations without lengthy implementation timelines or complex IT requirements.

Controlled Document Management

• Supports authoring, editing, review, and approval of SOPs and other controlled quality documents.
• Controls user permissions and document access by user role.
• Enforces naming conventions by document type.
• Uses templates to maintain consistency and automate document generation.
• Supports customizable workflows for authoring, editing, review, and approval.
• Includes an audit-ready simple approval process as well as DocuSign integration for electronic signatures.
• Built-in reporting tracks document status, effective dates, renewal dates, and more.

Quality Events

• Supports creation, management, and tracking of quality events using configurable event forms, templates, and workflows.
• Covers Incidents and Complaints, Deviations and Non-Conformances, Risk Evaluations, Change Control Processes, and CAPA Management.
• Automatically generates documents based on existing Quality Event templates.
• Provides customizable reporting with dashboards and automated report distribution to team members.

Audit Management

• Supports internal, vendor, and partner audits within the QMS.
• Includes an 'Inspector' user role specifically designed for remote audits.
• Vendor and supplier audits are managed through the Vendor Management area, with automatically generated forms, documents, and audit project plans.
• Internal audits can be linked to other quality events such as Risk Evaluations or CAPAs.
• The system is maintained in an audit-ready and diligence-ready state at all times.

Vendor and Supplier Management

• Manages all vendor-related qualification forms and documents in one place.
• Captures key vendor and supplier information including approval status and renewal dates.
• Uses built-in project management tools to plan and track regular vendor activities.
• Provides configurable reports for vendor dashboards and automatic status reports.

Training Management

• Allows teams to build courses from content stored in Kivo, including SOP documents, videos, and presentations.
• Supports user enrollment in courses by role, department, or individually.
• Training reports track compliance by course, element, and employee.
• Supports linking to external training content and uploading training records for storage.
• Training is directly linked to the Document Management System.

Platform Features and Technical Capabilities

• Approval workflows with Part 11 compliant electronic signatures.
• Smart document placeholders and pre-structured, customizable project templates.
• Auto-association of projects to tasks and tasks to documents.
• Intelligent reporting and automated alerts.
• Document linking with aliasing, removing the need for multi-indexing.
• Integration with Microsoft Office Online.
• Customizable metadata across features.
• Role-based, per-user licensing covering full platform, limited access, and third-party access.
• Access to Kivo's eTMF, eCTD, and RIM modules is included with no separate integration required.
• Fully cloud-based with no IT infrastructure required; supports single sign-on and is browser-based for PC and Mac.

Security and Compliance

• Built to meet GCP/GxP compliance requirements for the life sciences industry.
• Conducts quarterly data integrity checks at no additional cost.
• Software updates are pre-validated and delivered with complete documentation.
• Integrated CFR Part 11 compliant electronic signatures are included throughout the platform.

Implementation and Support

• Implementation is designed to be completed within weeks, supported by Kivo's pre-validation process.
• 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.