EASY VENDOR AUDITS & LIFECYCLE MANAGEMENT
Vendor Audit Management Software for Life Sciences
Kivo QMS makes it easy to manage vendor audits, documentation, and oversight in one cloud-based, Part 11–compliant system that adapts to your SOPs.

Vendor Management & Compliance
Kivo brings consistency and automation to the vendor auditing process
Today’s teams and trials leverage outsourced vendors and partners more than ever before. But with that comes the need to manage those vendor relationships in a compliant way - including legal and contractual information, certifications, classifications, license expiration dates, regular audits and more. Kivo’s vendor management capabilities simplifies and streamlines vendor management, even for smaller teams.
VENDOR AUDITS
A simple system for all your vendor contracts & audits
Kivo’s intuitive Quality Management System makes it easy to manage all your vendor-related materials. Associate each vendor with a unique ID, status, certifications, audit date(s), contact information, and more. Track the status of a vendor audit or compliance-related activity. And if a vendor audit necessitates a CAPA, Kivo will automatically create a project from a customizable template, complete with tasks, due dates, and placeholders for related documentation.

Vendor Audit Benefits Include
Centralized Vendor Information
Easily manage vendor status & materials in Kivo’s intuitive Quality Management System - including contracts, certifications, classifications, license expiration dates, regular audits and more
Vendor Qualification
Track vendor qualification by using a templated project, maintaining consistency across all your vendors and partners. Projects can be customized to match your SOPs.
Audit Project Management
Streamlined audit management with projects, tasks, milestones and reporting for all audit-related activities.
Link to CAPAs or Events
Associate CAPAs or other event types with the related vendor. Each event includes a project template (customizable of course) that you can manage within Kivo.
Intelligent Reporting
Want to know which certifications are expiring in the next 90 days? No problem. Want that report delivered to your inbox each week? Done. Skip the report if nothing new? You got it.
Part 11 Compliant
Validated and Part 11 Compliant, Kivo follows best practices for GxP as well as cloud security. Single Sign On, with no IT needed.
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Workflow with Kivo
See how Kivo can help your team reduce manual work and improve compliance.


For pharmaceutical and biotech companies, vendor management software must support stringent regulatory requirements and quality assurance processes. Key features include vendor qualification workflows, audit trail capture, document management, risk scoring, and integrated CAPA tracking. Systems should also support controlled access and electronic signatures in compliance with 21 CFR Part 11.
Equally important is usability. Teams need dashboards to monitor vendor performance, reminders for requalification, and tools for tracking supplier documentation like certificates, audit reports, and contracts. Bonus points for software that integrates with your broader QMS or regulatory systems to eliminate rework and manual entry.
FAQs
A vendor management audit is a formal review of a supplier’s compliance with your company’s quality standards, regulatory requirements (such as GxP, ISO 13485, or 21 CFR Part 11), and contractual obligations. These audits are a critical part of supplier oversight in life sciences, helping ensure that third-party vendors do not introduce risk to your product quality, patient safety, or inspection readiness. Audits typically include reviewing documentation, assessing risk, identifying gaps, and verifying corrective actions.
Kivo simplifies the entire process by centralizing vendor data and standardizing workflows. You can assign vendor criticality, track audit schedules, and use customizable audit templates to ensure consistency across audits. When an audit is triggered, Kivo can automatically generate tasks, send reminders, and capture findings in a structured format that links directly to CAPAs when needed. Real-time dashboards show upcoming audits, expiring qualifications, and open issues, giving QA and Compliance teams the visibility they need to stay proactive, not reactive. With built-in audit trails and version control, Kivo helps ensure that every audit record is complete, traceable, and inspection-ready.
Managing vendor audits in a GxP-compliant way starts with maintaining accurate, audit-ready documentation for every vendor interaction. You need a centralized system that tracks qualifications, CAPAs, audit findings, and performance reviews. A Part 11–compliant platform like Kivo ensures that all changes are logged with electronic audit trails, signatures, and version control, key components of GxP expectations.
Beyond documentation, GxP compliance requires defined, repeatable processes. Your vendor audit process should be mapped to your SOPs, with clear templates and workflows for planning, conducting, and following up on audits. This helps you ensure consistency and preparedness, especially during FDA or global health authority inspections.
Tracking vendor performance starts with defining metrics that matter: on-time delivery, audit findings, responsiveness, deviation rates, and more. A good vendor management system allows you to score, segment, and visualize vendor performance over time so you can take action when risk levels rise.
For life sciences, risk isn’t just about operational failure. It's also about regulatory exposure. Kivo allows you to tag vendors by criticality, track qualification status, and link audit findings directly to CAPAs within the QMS. These capabilities help life sciences teams proactively manage vendor risk, maintain continuous compliance, and stay inspection-ready.
Compliance during vendor onboarding starts with having documented, repeatable processes: qualification questionnaires, risk assessments, SOP-aligned workflows, and signed agreements. All of this should be captured and stored in a validated, audit-ready system.
Ongoing monitoring involves reviewing performance metrics, scheduling periodic audits, and updating documentation like ISO certs and contracts. With a system like Kivo, these activities are automated through reminders, dashboards, and configurable workflows, so you can demonstrate continuous oversight with minimal administrative burden.
The best vendor management software for life sciences is one that balances regulatory compliance, flexibility, and usability. Life sciences teams need more than basic procurement tools. They need a system that can handle GxP requirements, audit trails, and documentation workflows that align with 21 CFR Part 11 and ISO standards. Solutions like Kivo are built specifically for regulated industries, providing a single platform to manage vendor qualification, oversight, audits, and performance tracking.
Additionally, the best software should adapt to your SOPs rather than forcing you into rigid templates. Kivo offers configurable workflows, customizable forms, and robust reporting tools that simplify audit prep and vendor monitoring. Integration with your QMS or document management system is also critical to avoid silos and ensure traceability across your quality ecosystem.
Yes, Kivo’s vendor management software allows you to fully customize audit report templates so they align with your organization's SOPs, regulatory requirements, and internal quality standards. This ensures that every vendor audit follows a consistent structure, whether you're evaluating a critical supplier or performing a routine requalification.
Unlike generic tools, Kivo’s vendor management software is purpose-built for life sciences, which means it supports the structured, audit-ready documentation required under GxP and 21 CFR Part 11. You can tailor your templates to include specific risk criteria, scoring systems, corrective action fields, or regulatory checklists, all while maintaining traceability through built-in version control and electronic signatures. This flexibility helps ensure both consistency across your team and compliance across your vendor network.
Kivo’s Quality Management System is built specifically for life sciences teams and supports full compliance with 21 CFR Part 11, GxP guidelines, and ISO standards. As both a QMS and a vendor management software solution, Kivo gives teams the tools to manage supplier qualification, track certifications, conduct audits, and document CAPAs, all within a validated, inspection-ready environment.
Unlike general-purpose systems, Kivo’s vendor management software is natively integrated with its QMS functionality, eliminating silos between quality processes and supplier oversight. This means audit findings can seamlessly trigger CAPAs, expired certifications prompt alerts, and all changes are logged with electronic audit trails and signature tracking. For life sciences companies navigating global regulations and complex supply chains, Kivo offers a streamlined, compliant, and highly configurable solution.
Absolutely. Kivo’s vendor management software includes intelligent reporting tools that let you schedule automated reports for critical compliance activities, including upcoming vendor certification expirations, qualification status changes, and audit outcomes. For example, you can set up a report that automatically flags any certifications expiring within the next 30, 60, or 90 days, helping your team take timely action and avoid lapses that could impact inspection readiness.
This automation is especially valuable in regulated environments where documentation gaps can lead to audit findings or product delays. With Kivo, vendor certification data is centralized and continuously monitored, and reports can be sent to stakeholders on a recurring schedule, no manual follow-up needed. It’s vendor management software designed to keep life sciences teams ahead of compliance risks with minimal administrative overhead.
Kivo’s vendor management software is built to meet the rigorous compliance and security standards required in the life sciences industry. The platform is fully 21 CFR Part 11 compliant, validated for GxP use, and adheres to industry best practices for electronic records, audit trails, and data integrity. Kivo is also SOC 2 Type II certified, demonstrating its commitment to secure, reliable cloud infrastructure that meets the expectations of both regulatory bodies and IT security teams.
In addition to robust technical controls, Kivo supports Single Sign-On (SSO) for secure and seamless user access, helping organizations enforce authentication policies across their quality and vendor systems. With centralized vendor oversight and automated audit tracking, Kivo’s vendor management software gives life sciences teams the confidence to manage compliance without compromising speed or usability. You can learn more about our certifications and security practices by visiting our trust center!