Vendor Audit Management Software for Life Sciences

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.