Audit Management

Simplify Audits. Strengthen Compliance.

Automate and manage internal, external, and supplier audits with ease. Grand Avenue’s Audit Management module helps medical device companies stay compliant with FDA and ISO standards — while saving time and reducing risk.

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Streamlined Audit Management

  • Manage internal, external, and supplier audits in one system
  • Assign roles, define scope, and schedule audits with ease
  • Track findings with built-in, compliant templates
  • Link nonconformances directly to CAPAs and action plans
  • Generate audit summary reports with clear, organized results

Define and Track Audit Requirements with Confidence

Use built-in templates to quickly populate each audit with standardized, regulatory-ready requirements. Grand Avenue ensures every audit starts with the right foundation — saving time while supporting ISO and FDA compliance.

Grand Avenue Software - Manage Audit

Turn Audit Findings into Clear, Actionable Reports

Automatically generate a structured summary of nonconformances, observations, and next steps. Grand Avenue’s Audit Findings Report keeps results organized and linked to CAPAs — helping your team move from review to resolution with speed and confidence.

Ready to simplify your audit process?

Ensure compliance and gain full oversight with Grand Avenue’s Audit Management module — built specifically for medical device teams navigating FDA and ISO standards.

Schedule, execute, and track internal, external, and supplier audits in one connected system. Use pre-built templates to define requirements, link findings directly to CAPAs, and generate clear, actionable reports — all within an audit-ready platform that reduces risk and increases efficiency.

Request a Demo today to see how Grand Avenue can help your team manage audits with less effort and more confidence.


Frequently Asked Questions

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How does Grand Avenue Software’s Audit Management module ensure compliance with ISO 13485 and FDA regulations?

Grand Avenue Software’s Audit Management module ensures compliance with ISO 13485 and FDA regulations by providing tools for scheduling, conducting, and tracking audits. It includes automated workflows, audit trails, and corrective action tracking to meet regulatory requirements, ensuring thorough documentation and real-time visibility into audit processes.

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What are the benefits of using pre-defined audit templates in Grand Avenue’s Audit Management solution?

Using pre-defined audit templates in Grand Avenue’s Audit Management solution saves time, ensures standardization, and aligns audits with regulatory requirements. These templates help maintain consistency, reduce human error, and speed up the audit preparation process.

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Can Grand Avenue Software manage both internal and external audits efficiently?

Yes, Grand Avenue Software efficiently manages both internal and external audits by providing tools for scheduling, tracking, and documenting audit activities. It ensures compliance through automated workflows, real-time tracking, and audit trails, making the process seamless for both types of audits.

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What audit findings can be tracked using Grand Avenue’s Audit Management tool?

Grand Avenue’s Audit Management tool tracks key findings such as non-conformities, process deviations, regulatory issues, and corrective actions. It allows for documenting observations, assigning corrective actions, and tracking resolution to ensure compliance with regulations like ISO 13485 and FDA guidelines.

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Is Grand Avenue’s Audit Management module scalable for growing medical device companies?

Grand Avenue’s Audit Management module is highly scalable, supporting companies as they grow from small startups to larger enterprises. It allows for managing an increasing volume of audits and offers customizable features and templates to adapt to evolving regulatory requirements and business needs.

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