10 eQMS Mistakes to Avoid During Your First Audit
Your first audit using an electronic Quality Management System (eQMS) is a major milestone, and a potential stress test. Preparing for an ISO certification, FDA inspection, or customer audit requires an eQMS that performs reliably -and is used effectively- to ensure a successful outcome.
While eQMS platforms like Trackmedium eQMS are built to make audits smoother and more transparent, companies often fall into avoidable traps when adopting digital tools for regulated quality processes.
To help you stay confident and compliant here are 10 common eQMS mistakes to avoid during your first audit, and what to do instead.
1. Incomplete or Inaccurate User Access Controls
One of the first things auditors check is who has access to what, and why. Shared logins, inactive accounts, or missing role-based controls raise immediate red flags.
What to do:
Implement strict role-based access permissions, ensure user lists are regularly reviewed, and deactivate accounts promptly when roles change.
2. Missing or Unreviewed Audit Trails
Your eQMS should maintain tamper-proof audit trails of who made changes, when, and why. If your audit logs are incomplete, inaccessible, or ignored, you risk failing traceability checks.
What to do:
Ensure all critical records (SOPs, CAPAs, NCRs) have visible audit histories, and review them periodically. Be ready to show auditors how the system captures and preserves this data.
3. Not Validating Your eQMS for Intended Use
In regulated industries, using an unvalidated eQMS is a serious compliance issue. If you can’t show that the system was tested and performs as intended, auditors may question the reliability of your data.
What to do:
Follow validation best practices (e.g., GAMP 5), maintain validation protocols and test records, and confirm any post-implementation changes are also validated.
4. Outdated or Uncontrolled Documents
Even with an eQMS, teams sometimes upload uncontrolled documents or forget to archive outdated versions. During audits, this can result in findings related to document control and version management.
What to do:
Use your eQMS to enforce document review cycles, approval workflows, and automatic versioning. Archive superseded documents correctly.
5. Untrained Users and Incomplete Training Records
Auditors often request training records, especially for users responsible for critical quality activities. If the training module isn’t kept current, you may be unable to prove employee qualification.
What to do:
Ensure training assignments are up to date and that completions are automatically tracked in your eQMS. Use reports to demonstrate compliance.
6. CAPAs Not Linked to Root Cause or Verification
Corrective and Preventive Actions (CAPAs) are often scrutinized. Auditors want to see clear linkage between findings, root cause analysis, implemented actions, and effectiveness checks.
What to do:
Use eQMS CAPA workflows that require root cause documentation, assign responsible parties, and enforce follow-up verification before closure.
7. Over-Reliance on Manual Workarounds
Using external spreadsheets, email approvals, or disconnected systems alongside your eQMS defeats its purpose, and creates audit risks due to poor traceability or version conflicts.
What to do:
Centralize as much of your quality system as possible within your eQMS. Avoid parallel systems unless absolutely necessary, and document their use clearly.
8. Failure to Prepare Mock Audit Scenarios in the eQMS
Going into your first audit without testing your system under realistic audit conditions can lead to surprises; missing reports, awkward navigation, or hard-to-access records.
What to do:
Conduct internal mock audits using your eQMS interface. Practice pulling reports, retrieving documents, and navigating audit trails live as you would during the real thing.
9. Inadequate Supplier and External Audit Records
Your eQMS should also help manage supplier qualifications, external audit results, and related follow-ups. If these records are stored inconsistently, you may miss critical findings during audit prep.
What to do:
Maintain a central repository for supplier records, audits, scorecards, and approved vendor lists, all traceable within the system.
10. Ignoring System Notifications and Expiry Reminders
Modern eQMS platforms like Trackmedium issue reminders for document reviews, CAPA due dates, training renewals, and more. Ignoring these alerts can result in overdue tasks that get flagged during the audit.
What to do:
Make it standard practice to monitor and act on system alerts. Configure escalations or dashboards to track time-sensitive items.
Conclusion
Your first audit with an eQMS doesn’t need to be nerve-wracking. In fact, with the right preparation and proper use of your system, it can be your strongest asset for demonstrating control, transparency, and compliance.
Avoiding these 10 common mistakes helps ensure you walk into your next audit confident, organized, and ready to impress.
Trackmedium eQMS can make your next audit smoother. It streamlines documentation, automates compliance workflows, and gives you the visibility you need to stay fully prepared – from day one!
