Pre-Audit Checklist for Regulated Industries
Ensure your organization is always audit-ready with this comprehensive checklist.
Name
*
First Name
Last Name
Email
*
example@example.com
Phone Number
*
Please enter a valid phone number.
Company
*
1. Documentation Review
Ensure all required policies and procedures are documented and up to date.
Verify that document control systems are in place and version histories are maintained.
Confirm that policy updates are communicated and acknowledged by relevant personnel.
Maintain evidence of compliance training, including sign-off records and certifications.
Other
2. Compliance Management
Conduct a gap analysis to identify non-compliance areas.
Map current processes to regulatory requirements for alignment.
Implement corrective actions for past compliance issues and retain records of remediation efforts.
Maintain logs of regulatory changes and demonstrate updates to policies or procedures.
Other
3. Risk Assessment and Mitigation
Identify high-risk areas within operations (e.g., safety, quality, environmental).
Perform regular risk assessments and document findings.
Validate controls are in place to mitigate identified risks.
Document any incidents, investigations, and resolutions.
Other
4. Audit Trail and Recordkeeping
Maintain an organized, accessible repository of historical audit reports.
Keep accurate records of all activities related to compliance, including approvals and changes.
Ensure systems have reliable audit trails for tracking modifications and user activity.
Verify that records meet retention requirements specified by regulations.
Other
5. Training and Awareness
Ensure compliance training programs are completed by all relevant staff.
Keep records of training schedules, materials, and attendance.
Conduct periodic refresher training to address new or updated regulations.
Confirm that field personnel understand and follow operational procedures.
Other
6. Internal Audit Preparation
Conduct regular internal audits to identify and resolve issues proactively.
Schedule internal audits in alignment with external audit requirements.
Review internal audit findings and create an action plan to address gaps.
Document evidence of corrective actions and follow-ups.
Other
7. Policy Execution and Monitoring
Confirm that field personnel follow procedures as documented.
Use tools like PolicySync360 to track policy updates and field execution.
Perform spot checks or field audits to verify adherence to policies.
Regularly review feedback from field teams to identify improvement opportunities.
Other
8. Technology and System Readiness
Ensure systems used for compliance are fully operational.
Validate data integrity and ensure reports are generated accurately and on time.
Confirm access controls are in place to protect sensitive information.
Test system performance to prevent delays during external audits.
Other
9. Stakeholder Communication
Identify and prepare key personnel for audit interviews.
Maintain a clear audit response plan, including points of contact and escalation procedures.
Develop pre-audit briefings to align the team and clarify objectives.
Create templates for responding to common auditor questions.
Other
10. Post-Audit Follow-Up
Review audit findings and prepare a corrective action plan.
Communicate results and next steps with relevant stakeholders.
Monitor the implementation of corrective actions and track progress.
Retain records of the audit report, responses, and resolutions for future reference.
Other
Receive Your Checklist
Should be Empty: