KIVO QMS

A Quality Foundation for Growing Teams

Control your documents, manage quality activities & vendors, and keep track of training with Kivo's validated, Part-11 compliant Quality Management.

Fully Compliant, Less Complicated

Standardize (& streamline) Quality operations in Kivo’s user-friendly, pre-validated system. Built on our Part-11 compliant Document Management Platform, Kivo’s QMS allows teams to manage their Quality documents and processes without as many clicks.

Confidently Manage Quality Events & Documents

  • Controlled Documents
  • Quality Events
  • Audits
  • Vendors
  • Training

Controlled Documents

Kivo's QMS area leverages our Part-11 compliant Document Management System for authoring, editing, approval of SOPs and other key documents:

  • Control user permissions & document access by user role.
  • Enforce naming conventions by document type.
  • Use templates to maintain consistency and automate document generation.
  • Customize your workflows for authoring, editing, review & approval.
  • Includes audit-ready 'simple approval' as well as DocuSign for eSignature.

Quality teams also use Kivo's built-in Reporting to track document status, effective & renewal dates, and more.

Quality Events

Create, manage, and track all your Quality Events in Kivo. With highly configurable event forms, templates, and workflows - Kivo allows teams to establish compliant quality processes (or to streamline their existing ones).

  • Incidents & Complaints
  • Deviations & Non-Conformances
  • Risk Evaluations
  • Change Control Processes
  • CAPA Management

Save time with automatically generated documents based on your existing Quality Event templates. Use Kivo's customizable reporting to create dashboards and automatically send reports to your team.

Audits

Simplify and accelerate internal, vendor, and partner audits by leveraging Kivo's QMS.

  • With Kivo, your team is always Audit & Diligence-ready. We even include an 'Inspector' user role specifically for remote audits.
  • Vendor & Suppliers Audits are easy to manage using our Vendor Management area - with automatically generated forms, documents & even audit project plans.
  • Easily link Internal Audits to other Quality Events - such as Risk Evaluations or CAPAs - when needed.

Kivo offers your entire team a Part-11 compliant system system that is always audit-ready, so you can focus on the work at hand.

Vendor & Supplier Management

Kivo's QMS is a single system to manage all aspects of your vendor relationships.

  • Create & manage all Vendor-related qualification forms and documents.
  • Capture key vendor & supplier information and status - including approval status, renewal dates, and more.
  • Use Kivo's built-in project management to plan and track regular Vendor activities.
  • Leverage Kivo's configurable reports to create vendor dashboards and automatic status reports.

Kivo makes it easy to see and manage all your vendors and suppliers in one place - and stay on top of compliance requirements.

Training Management

It's easy to establish and manage a compliant training program with Kivo's QMS:

  • Build Courses from content stored anywhere in Kivo - including SOP docs, videos, and presentations.
  • Enroll Users in courses by role / department or individually.
  • Use our Training Reports to track and manage training compliance by course, element, and employee.
  • Link to external training content and upload training records for storage.

Kivo offers teams a simple and compliant way to manage training on SOPs, corporate policies & more - all as part of our audit-ready QMS.

Best in Class Security & Compliance

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.

Features that scale. Costs that don't.

Kivo QMS

  • QMS Features

  • Approval Workflows with Part 11 Compliant E-Signatures

    • Smart Document Placeholders
    • Pre-Structured & Customizable Project Templates
    • Secure Access and Viewing
    • Auto-Associate Projects to Tasks, and Tasks to Documents
    • Intelligent Reporting and Automated Alerts
    • Link Trainings Directly to the DMS

  • General Kivo Features

  • Access to eTMF, eCTD and RIM Included (No Integration Required)

    • Role-Based, Per User Licensing for Full Platform, Limited Access, and 3rd-Party Access
    • Document Linking with Aliasing (No Multi-Indexing Required)
    • Seamless Integration with Microsoft Office Online
    • Customizable Metadata Across Features

  • IT & Security

  • Integrated CFR Part 11 Compliant eSignatures

    • No IT Required (Fully Cloud Based)
    • 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

Support from Day 1

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

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.

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!)

Accelerate Quality Management

Get Kivo QMS today

Kivo QMS FAQs

What is a Quality Management System? A Quality Management System (QMS) for life sciences is a structured system that organizations use to manage and ensure the quality of their products and services in sectors such as pharmaceuticals, biotechnology, and medical devices. A QMS helps ensure compliance with regulatory requirements, enhances product safety and effectiveness, and promotes continuous improvement.

What does Kivo QMS do? Kivo QMS (Quality Management System) is a software solution designed to help organizations in the life sciences sector manage their quality processes effectively. Common quality processes include authoring and managing SOPs, overseeing CAPAs, Deviations, and Audits, and enabling required training across the organization and third party vendors.

What does CAPA stand for in Quality Management? CAPA stands for Corrective and Preventative Actions. It refers to a systematic process used to investigate, address, and prevent the recurrence of non-conformities or quality issues within an organization.

What is a QMS audit? A QMS audit (Quality Management System audit) is a systematic examination of an organization’s quality management processes and systems to determine their effectiveness, compliance with applicable regulations and standards, and alignment with organizational goals. Audits can be internal or external and typically follow a structured approach.

What does CAPA Certified mean? CAPA certified typically refers to an organization or individual that has undergone training and assessment related to Corrective and Preventive Actions (CAPA) within a quality management system. This certification indicates that they have a thorough understanding of CAPA processes, principles, and best practices. Certifications are offered by a variety of professional associations, training providers, consulting firms, and universities.

What does Kivo QMS cost? We pride ourselves on our affordability - visit our pricing page to learn more!