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.

Establish sustainable processes to ensure ongoing audit readiness.

Conform.

Identify discrepancies and determine actions to meet regulatory guidelines.

Ready.

Anticipatory as well as structured preparation of inspections by authorities and protection of the company against far-reaching official measures.

Is your goal "Every Day Audit Readiness"?

Our Approach.

Every Day Audit Readiness by Entourage Experts.

The far-reaching regulatory requirements in the pharmaceutical industry and its suppliers are subject to constant change. Compliance with process and quality standards requires continuous internal monitoring and adjustment as necessary in order to survive in the long term before auditing bodies such as authorities. During daily work routines, historically grown, practical, but no longer regulatory compliant workflows often become ingrained. Over time, some processes become obsolete or innovations lead to inconsistent interfaces between departments or implementation difficulties among employees. We identify weak points and support your potential for improvement:
  1. Independent and comprehensive evaluation of existing systems and processes
  2. Detection of nonconformities
  3. Summary of the results in the official audit report
  4. Consulting in consideration of regulatory requirements
  5. Evaluation of internal and external interfaces
  6. Offering solutions in balance between regulatory theory and practical implementation
  7. Determination of appropriate and sustainable measures
  8. Consulting during the implementation of measures
  9. Advice on setting up sound quality management systems
  10. Final evaluation of the audit and implementation
  11. Establishment of robust standards according to GMP and ISO
  12. Solid qualitative positioning between supplier and customer
  13. Optimal preparation for inspections by authorities
  14. Support in the follow-up of audits and inspections by authorities

Our Audit Offer.

Be best positioned within regulatory requirements:

Our Audit
Services.

Our Audit Promise.

What you can expect from Entourage's audit experts.

Effective.

Conform.

Ready.

Audit Expertise.

Get to know our audit experts.

Charis schmidt

Charis Schmidt

Senior Management Consultant

Auditor for GMP/GDP and ISO

Entourage team ralf hess

Dr Ralf Hess

Principal Consultant IVD

Auditor with many years of experience in the GxP/ISO area

Team website anastasia wolf

Anastasia Wolf

Principal Project Consultant

Auditor for ISO 13485

Our Case Studies.

Discover our Audit Case Studies.

Case Study.

Conducting audits.

Support with expertise and capacity.

Case Study.

Conduct mock audits.

Effectively prepare for government inspections.

Case Study.

Robust quality management

Establish robust (e)quality management processes and systems in a pharmaceutical manufacturing facility.

Case Study.

Establishment of a solid supplier management system and continuous monitoring

Risk-based classification of suppliers and implementation of supplier qualification.

Case Study.

Implementation of a company internal audit system.

System for effective review of internal departments.

Our blog.

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