Expertise.
Mock Audits.
Simulate realistic audits and close compliance gaps at an early stage.
Realistic?
Do our mock audits reflect the process of real certification or authority audits in practice?
Efficient?
Do you make optimum use of audit findings to improve your processes, documentation and teams in a targeted manner?
Secure?
Do you recognize compliance risks in good time and minimize cost-intensive deviations and rework?
Prepare yourself optimally for your next audit.
Mock Audits.
Effective preparation for certifications and compliance.
Mock audits offer you the opportunity to test your processes, documentation and teams under realistic conditions before an official audit takes place. Whether for ISO, GMP or MDR certifications: We simulate the entire audit process, identify weak points and provide targeted feedback for improvements. This helps you avoid surprises during the actual certification or official inspection.
Our services include:
- Audit planning and scope definition
- Carrying out realistic mock audits
- Gap analysis and recommended measures
- Audit follow-up and team workshops
Mock audits - your safe dress rehearsal for certifications.
Our methodology enables you to identify all critical audit areas and take countermeasures at an early stage.
Preparation and planning.
- Assembling a team of experts to take on the role of external auditors
- Definition of key audit areas (e.g. documentation review, production tour, interview with employees)
- Definition of the schedule and responsibilities
Implementation and documentation.
- Recording of all findings in audit logs
- Evaluation of process and documentation quality in comparison with relevant standards
- Direct feedback to those responsible and initial solution approaches
Follow-up and optimization.
- Presentation of a final report with prioritization of the fields of action
- Development of concrete action plans for process optimization, employee qualification and documentation improvement
- Success check through follow-up measures or renewed mock audit (optional)
Case studies - Successful mock audits in practice.
Our mock audits help companies to optimally prepare for certifications and official inspections.
GMP production - ensuring audit readiness
ISO 13485 Mock Audit - Preparation for initial certification
MDR compliance mock audit - ensuring compliance with the new requirements
Internal mock audit - preparation for customer audit
FDA 510(k) Mock Audit - Market access for medical devices
Challenge.
A pharmaceutical manufacturer wanted to have its production processes and documentation comprehensively checked before an official inspection.
Measures.
- Implementation of a complete GMP audit
- Interviews with production employees
- Review of batch documentation
- Tour of the production facility
Results.
- Detection of missing SOP updates
- Insufficient training certificates recognized
- Potential for improvement in hygiene regulations identified
Success.
Timely rectification of all defects, smooth official inspection and extension of the production permit.
Ensure your audit readiness with practical mock audits.
Our mock audit service - success through realistic auditing.
With our mock audits, you can identify weaknesses before they become a problem in official inspections.
We offer a detailed assessment of identified deviations and the development of tailored optimization strategies. In doing so, we take into account the regulatory requirements of the
FDA,
EU Medical Device Regulation and
TGA Australia.
Our team supports you in implementing the proposed measures and offers targeted training to ensure audit readiness. In doing so, we rely on official guidelines such as the
WHO GMP recommendations.
As part of our mock audits, we carry out a systematic risk analysis in order to identify critical weaknesses at an early stage. In doing so, we are guided by international standards such as
ICH Q9.
Ensure the quality of your processes and minimize risks.
Further topics relating to mock audits.
Mock audits are an important part of audit preparation and compliance assurance. To get a comprehensive overview of related topics and specific requirements, you can find further content here: