Audit and Inspection Readiness

At Horgen Medical, we understand that successful clinical trials are subject to rigorous regulatory scrutiny. Our Audit and Inspection Readiness solution is designed to prepare your clinical trials for every aspect of regulatory audits and inspections, ensuring that you are fully compliant and ready to address any findings efficiently.

1. Comprehensive Preparation

Preparation is key to a successful audit or inspection. Our team begins by conducting a thorough review of your clinical trial processes, documentation, and compliance status. We identify potential gaps and areas for improvement, providing you with a detailed action plan to address any issues before the audit or inspection occurs.

• Documentation Review: We examine all trial-related documents, including protocols, informed consent forms, and data records, to ensure they are complete, accurate, and compliant with regulatory standards.
• Process Assessment: We evaluate your trial processes and procedures to identify any weaknesses or inconsistencies that could raise concerns during an audit.

2. Training and Support

Proper training is essential for ensuring that your staff is well-prepared for an audit or inspection. We provide comprehensive training for your team on audit and inspection procedures, helping them understand what to expect and how to respond effectively.

• Staff Training: We offer tailored training sessions for your clinical and administrative staff, focusing on best practices for handling audits and inspections.
• Mock Audits: We conduct mock audits to simulate real inspection scenarios, providing your team with practical experience and valuable feedback.

3. Ongoing Monitoring and Compliance

Maintaining compliance throughout the trial is crucial for audit readiness. Our team offers continuous monitoring to ensure that your trial remains in adherence to regulatory requirements and industry standards.

• Compliance Checks: We perform regular compliance checks to identify and address any issues promptly, reducing the risk of non-compliance during an audit.
• Corrective Actions: If any deficiencies are identified, we work with you to implement corrective actions and preventive measures to ensure ongoing compliance.

4. Responding to Findings

In the event of an audit or inspection, our team provides expert support to address any findings or concerns raised by regulators. We assist in preparing responses, implementing corrective actions, and communicating effectively with regulatory authorities.

• Finding Resolution: We help you develop and implement solutions to address any findings or deficiencies identified during the audit.
• Regulatory Communication: Our team supports you in communicating with regulatory authorities, ensuring that all issues are resolved promptly and effectively.

5. Post-Audit Support

The end of an audit or inspection is not the end of our support. We provide post-audit assistance to ensure that any required changes are implemented and that your trial remains compliant moving forward.

• Action Plan Development: We assist in developing and implementing action plans based on audit findings, ensuring that necessary changes are made.
• Follow-Up: We conduct follow-up reviews to verify that corrective actions have been successfully implemented and that compliance is maintained.