Audit Management Software for ISO and FDA Compliance
Streamline internal, external and supplier audits with automated workflows, real-time tracking and built-in CAPA integration—all in one, easy-to-use QMS.
Audit to Any Standard
Prepare for audits under one or multiple standards.
Auto-Link CAPA
Auto-generate CAPAs from audit findings.
Speed Up Audits
Automate tasks to reduce prep time and speed up processes.
Centralize Records
Store reports, evidence and approvals in one online location.
Built-In Compliance Tools
Includes audit trails and FDA 21 CFR Part 11 electronic approvals.
Real‑Time Tracking
Dashboards show audit status, tasks and nonconformances.
What is audit management software?
Audit management is the process organizations use to plan, execute, document and follow up on audits to ensure compliance with internal policies and external standards. It plays a critical role in quality management systems (like ISO 9001, FDA and GMP) by helping companies identify gaps, monitor effectiveness and drive continuous improvement. The goal is to provide accountability, reduce risk and ensure operational consistency.
QT9’s audit management software streamlines the entire audit lifecycle. From scheduling and assigning audits to tracking findings, approvals and corrective actions, QT9 helps automate every step. Fully integrated within the QT9 QMS, it simplifies internal, external and supplier audits, helping companies stay audit-ready and compliant with industry regulations.
All-in-one solution for better audit management
Free up time with user-friendly audit tools built in to QT9 QMS.
Automated Audit Prep
Get full visibility into missing records, overdue tasks and audit risks.
Electronic Records
Custom Checklists
Create custom quality standard checklists for custom audits.
Manage Approvals
Assign approver/s and approve, reject or verify audit records.
Email Alerts
Send and receive email alerts and reminders on upcoming audits.
Audit Scheduling
Keep track of your audit schedule from anywhere with web access.
Attach Related Files
Attach unlimited files to any audit (great for attaching 3rd party registrar audit report).
Real-Time Reporting
Assist with data mining and trend analysis with charts and graphs.
Link Documents
Link processes to document control for ease of use in auditing.
Create Corrective Actions
Third-Party Audits
Any Standard
Celebrated by Experts. Loved by Customers.
QT9 QMS is a leader in Audit Management Software on Capterra and Software Advice.
Centralize data with 25+ modules
FAQ: Audit Management
In the quality management arena, audit management is an integrated system that links all of the data and documentation necessary to ensure audit objectives are met, including regulatory compliance. The goal of audit management is to maintain audit preparedness by organizing and simplifying all parts of an audit.
Audit management software facilitates every stage of the audit process, from planning and scheduling to generating final reports, and improving the efficiency and accuracy of the audit process. It automates the process of preparing and executing audits by helping companies analyze data, assess risks, track issues, report results and centralize documentation. Regulatory compliance is streamlined and simplified with centralized workflows and full traceability.
There are three types of audits that are prevalent in quality management: internal, regulatory and supplier.
An internal audit is conducted by an organization’s own audit department or quality team with the goal of evaluating and potentially enhancing the organization’s systems.
A regulatory audit is conducted by an independent, third-party auditor with the goal of assessing the organization’s compliance with regulatory standards.
A supplier audit is an external audit conducted when an organization audits their suppliers to ensure compliance to regulatory and industry standards.
QT9 QMS is built to simplify regulatory compliance at all stages, especially the audit stage. By integrating multiple modules into audit management, such as document control and corrective actions, QT9 QMS can eliminate time wasted on preparing for audits and responses to audit findings. Creating audit schedules for internal, external, supplier and customer audits, with email alerting and custom audit checklists, ensures that your entire audit process is as efficient as possible.
QT9 QMS is a highly rated solution loved by customers. We offer more than 25 modules standard, including Audit Management and Document Control with 21 CFR Part 11-compliant electronic signatures.
We also offer an easy user interface, free software updates, full customer support, an ERP integration and Business Intelligence tool. Reach out today to learn more.
Yes. Audit management software is designed to support compliance with standards such as ISO 9001, ISO 14001, and other regulatory frameworks by centralizing audit planning, execution, findings, and follow-up actions. QT9 audit management software helps organizations maintain structured, audit-ready compliance across quality and regulatory requirements.
Implementation timelines vary based on organization size, complexity, and existing processes. Many modern, cloud-based audit management solutions can be implemented in weeks rather than months. QT9 provides configurable workflows and guided onboarding to help teams get up and running efficiently.
Yes. Audit management software commonly integrates with ERP, QMS, CRM, and other business systems through APIs or native integrations. QT9 audit management software connects with other quality and operational systems to ensure audit data, corrective actions, and documentation stay aligned across the organization.
Audit management software improves efficiency by automating routine tasks, replacing manual spreadsheets, reducing data entry errors, and providing centralized reporting and dashboards. QT9 helps audit teams streamline audit cycles, track findings in real time, and link issues directly to corrective actions.
Additional quality resources
FDA QMSR Part 2: Preparing for FDA Inspections
QT9 QMS Earns 2026 Top Honors from Capterra and Software Advice
FDA QMSR Compliance Calls for a New Mindset
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