Expertise.
Audit consulting for ISO and GxP.
Ensuring compliance and audit preparation through professional advice and process optimization.
Effective.
Sustainable processes to ensure permanent audit readiness.
Conform.
Detection of weaknesses and fulfillment of regulatory requirements.
Ready.
Structured preparation for inspections by the authorities to ensure compliance.
Are you ready for "Every Day Audit Readiness"?
Comprehensive audit consulting for ISO and GxP conformity.
Our experts support you in identifying non-conformities, meeting regulatory requirements and preparing your processes for upcoming audits and inspections.
ISO and GxP compliance:
We review your operations and systems to ensure you are compliant with all ISO and GxP standards, including ISO 9001, ISO 13485, GMP, GDP and GLP.
Audit preparation:
We help you prepare for upcoming regulatory audits and inspections, including optimizing your documentation and processes.
Mock audits:
Conducting realistic mock audits to identify weaknesses early and improve audit readiness.
Follow-up of audits:
Support in implementing corrective actions and following up on agency inspections to ensure long-term compliance.
We review your operations and systems to ensure you are compliant with all ISO and GxP standards, including ISO 9001, ISO 13485, GMP, GDP and GLP.
Audit preparation:
We help you prepare for upcoming regulatory audits and inspections, including optimizing your documentation and processes.
Mock audits:
Conducting realistic mock audits to identify weaknesses early and improve audit readiness.
Follow-up of audits:
Support in implementing corrective actions and following up on agency inspections to ensure long-term compliance.
ISO and GxP audit consulting - your processes put to the test.
Our ISO and GxP audit services ensure that your processes, systems and documentation meet the highest regulatory requirements.
Regulatory adjustments & audit preparation.
- Ensuring compliance with new ISO and GxP requirements by proactively adapting processes and systems.
- Support with complete documentation and preparation for complex official inspections and audits.
- Development of measures to reduce audit errors and optimize audit compliance.
Technological integration & automation.
- Implementation of advanced digital solutions to automate audit processes and improve ISO and GxP compliance.
- Integration of real-time monitoring systems that ensure efficient and transparent process control.
- Optimization of system compatibility for seamless traceability and improved audit compliance.
Risk management & quality control.
- Implementation of strategies for early detection and mitigation of production risks to ensure compliance with GxP and ISO standards.
- Improving data integrity and introducing systems to continuously monitor and ensure product quality.
- Introduction of robust preventive measures to minimize quality and compliance risks in your company in the long term.
Case Studies.
Our case studies in ISO / GxP audit preparation.
Audit preparation for ISO 13485 at a medical technology company
Resolution of FDA warning letters for a pharmaceutical company
Improving audit readiness at a global pharmaceutical company
Increasing audit readiness and compliance through comprehensive audit consulting.
A global pharmaceutical company was struggling to meet the requirements of GxP and ISO audits, leading to repeated complaints during inspections.
Measures.
- Carrying out a comprehensive mock audit to uncover weaknesses in the existing processes.
- Adaptation of existing quality management systems to meet ISO and GxP requirements.
- Staff training to improve compliance and prepare for upcoming audits.
Results.
- 25% fewer complaints in follow-up audits.
- Significant improvement of internal processes and documentation for compliance with ISO and GxP guidelines.
- Long-term audit readiness through regular internal audits.
Success.
Audit readiness was significantly improved within 6 months and the company successfully passed the following audits.
Are you ready for "Every Day Audit Readiness"?
Audit consulting - Our services at a glance.
Our comprehensive audit compliance consulting services cover all key areas to ensure that your processes and systems are compliant with regulatory requirements.
- ISO 9001 and GxP compliance audit
- Audit preparation and support
- Implementation of mock audits
- Follow-up of audits and inspections
- Advice on GMP, GDP, GLP, ISO 13485, ISO 11137
- Support with FDA inspections and rectification of warning letters
- Training and further education on ISO and GxP
- Implementation of robust quality management systems
Entourage is looking for life science experts.
Become part of our team.
