Audits GxP / ISO.
Entourage helps clients identify nonconformities and address them sustainably to ensure daily audit readiness. We review your company's processes, identify inconsistencies, and advise you on how to adapt to regulatory requirements and prepare for government inspections.
In the pharmaceutical environment, in addition to robust process flows and quality management systems, controls in the form of audits and inspections are regulatory requirements. Authorities regularly check how these requirements are implemented and complied with in companies. Every pharmaceutical company, as well as the associated suppliers and service providers, must meet the regulatory requirements for the processes, systems and quality of the products supplied. Audits and inspections are the common tools used to verify compliance. Based on this, companies obtain the respective certifications and regulatory approvals to be allowed to supply customers and patients with products and services.
Thus, a sustainable establishment of processes and systems as well as preparation for audits and inspections is indispensable. At the same time, regulatory adjustments require a constant awareness of the given specifications and regular improvements. In the end, meeting the high qualitative standards ensures the safety and continuous care of patients as well as the durability of your company.
Only with the right expertise and establishment of robust standards will quality be sustained.
Effective.
Conform.
Ready.
Is your goal "Every Day Audit Readiness"?
Our Approach.
Every Day Audit Readiness by Entourage Experts.
- Independent and comprehensive evaluation of existing systems and processes
- Detection of nonconformities
- Summary of the results in the official audit report
- Consulting in consideration of regulatory requirements
- Evaluation of internal and external interfaces
- Offering solutions in balance between regulatory theory and practical implementation
- Determination of appropriate and sustainable measures
- Consulting during the implementation of measures
- Advice on setting up sound quality management systems
- Final evaluation of the audit and implementation
- Establishment of robust standards according to GMP and ISO
- Solid qualitative positioning between supplier and customer
- Optimal preparation for inspections by authorities
- Support in the follow-up of audits and inspections by authorities
Our Audit Offer.
- GMP
- GDP
- GLP
- ISO 9001
- ISO 13485
- ISO 11137
- Mock audits
- Experience with various international authorities (incl. FDA)
- Experience in FDA Warning Letter resolution
- International audits
Our Audit
Services.
- Conducting audits (processes, systems and documents)
- Mock audits
- Preparation of companies for inspections by authorities
- Establishment of supplier qualification systems
- Establishment of internal audit systems
- Consulting for the development of pharmaceutical quality assurance systems
- Consulting regarding regulatory requirements in pharmaceutical production
- Support in the implementation of robust quality management systems
- Support in the follow-up of authority inspections
Our Audit Promise.
What you can expect from Entourage's audit experts.
Effective.
- Fast and in-depth capture of your processes and systems
- Sound evaluation with regard to relevant regulations
- Determination of sustainable measures
- Support in the implementation process
- Efficient balance between theory and practice
Conform.
- Reliable comparison with relevant regulations
- Alignment of blind spots with regulatory requirements
- Establishment of systems that are stable in the long term
Ready.
- Preparation for inspections by authorities
- Prevention of far-reaching authority measures
- Consistent positioning in the corporate environment by means of qualitative standards
Audit Expertise.
Get to know our audit experts.
Dr Ralf Hess
Auditor with many years of experience in the GxP/ISO area
Our Case Studies.
Discover our Audit Case Studies.
Our blog.
The latest articles.
