Expertise.
Inspection Readiness.
Ensure that your products and processes comply with regulatory requirements.
Complete?
Are your documentation and processes complete and ready for an official inspection?
Compliant?
Do your internal processes comply with regulatory requirements and GxP standards?
Secure?
Are you sure that your audits and inspections are carried out without any complaints?
Ensure complete audit preparation.
Inspection Readiness - Successful preparation for audits and inspections.
Our Inspection Readiness Service helps you to optimally prepare for upcoming official audits and inspections.
The requirements for audit preparation and compliance with regulatory provisions are constantly increasing. We help you to prepare your internal processes and documentation so that you can pass any regulatory inspection safely and without objections. Our team will analyze your current compliance situation and ensure that all required documents and processes meet the applicable standards.
Our services include:
- Audit preparation: Detailed review of all relevant documents and processes to ensure compliance.
- Employee training: Training courses and workshops to optimally prepare your team for upcoming audits
- Mock inspections: Carrying out internal simulations of inspections to identify and rectify potential weaknesses at an early stage.
Inspection Readiness Services at a glance.
Our comprehensive Inspection Readiness Services optimally prepare you for upcoming official audits and inspections.
Audit preparation.
- Review of all relevant documents and processes
- Ensuring compliance with regulatory requirements
- Preparation for MDR, FDA and international audits
Employee training.
- Training on GxP standards and regulatory requirements
- Preparation for the requirements of audits and inspections
- Workshops to improve internal processes
Mock inspections.
- Carrying out simulations of official inspections
- Identification and elimination of weak points in the documentation and processes
- Preparatory measures to ensure conformity
Successful projects in the area of inspection readiness.
Our inspection readiness projects help companies to optimize their audit preparations and meet regulatory requirements.
Preparation for an FDA inspection for a medical technology company
Audit preparation for a pharmaceutical company
Mock inspections for a biotechnology company
Challenge.
A biotechnology company wanted to ensure that it met all the requirements for an upcoming regulatory inspection.Measures.
- Carrying out a mock inspection to check the documentation and processes
- Identification and elimination of weak points in existing processes
- Training the team for optimal preparation for the inspection
Results.
- Early detection of potential vulnerabilities and their elimination
- Improved audit preparation and compliance
- Successful official inspection without delays
Success.
The company passed the inspection and was able to optimize its internal processes.Ensure successful audit preparation.
Our inspection readiness service portfolio.
Our inspection readiness portfolio offers you comprehensive support in preparing for regulatory audits and inspections. We ensure that your processes, documentation and employees are optimally prepared for regulatory audits and that your audit readiness meets the highest standards.
We review your processes and documentation in detail to ensure that all regulatory requirements are met. Our experts will prepare you specifically for audits in accordance with MDR, FDA and international standards. Further information can be found in the MDR/IVDR guidelines of the European Commission and the FDA guidelines.
We provide your employees with comprehensive training in GxP standards and prepare them optimally for upcoming audits. Our practice-oriented workshops improve internal processes and ensure that your team meets the regulatory requirements. You can find out more about this in the ICH GCP guidelines.
Our mock inspections simulate regulatory audits in order to identify weaknesses in your processes at an early stage and take preventative measures. These inspections optimally prepare your company for all types of regulatory audits.
We support you in managing and archiving all documents required for audits. We use automated systems to ensure audit-proof storage and easy retrieval. Further information on documentation standards can be found in the ISO 9001 guidelines.
Our experts continuously monitor changes in regulatory requirements and help you to keep your processes and documentation up to date. This proactive approach reduces risk and ensures ongoing compliance
We audit and evaluate your suppliers to ensure their compliance with GxP standards. This includes reviewing the entire supply chain and implementing preventive measures to minimize risks.
Following an audit, we support you in implementing corrective and preventive actions (CAPA) to eliminate weaknesses and achieve long-term improvements. Our experts work closely with you to efficiently implement regulatory requirements.
We develop and implement quality assurance systems that meet the specific requirements of MDR, FDA and other international regulations. With these systems, we guarantee seamless monitoring and documentation of your processes.
Optimize your complaint management and ensure regulatory compliance.
Related topics for your inspection preparation.
These complementary services help you to always be well prepared for audits and inspections to ensure compliance with regulatory requirements:
