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Our Audit Center

Our audit services

Drawing on two decades of expertise in Life Science and regulatory compliance, our Audit Centre provides audit and assessment services that measure the compliance and performance achieved by your organization and system, as well as your upstream or downstream partners.

We perform audits in the Life Science sectors:



PHARMACEUTICALS

Medicinal products, veterinary drugs, combbination drugs

CVO-EUROPE réalise des audits pour les industriels des dispositifs médicaux

MEDICAL DEVICES

MDs, IVDMDs

CVO-EUROPE réalise des audits dans le domaine des cosmétiques

COSMETICS

Our Audit and assessment services

AUDITS

To gain an outside perspective

 

An audit analyzes deviations in your system in light of new regulations and includes an audit report and observations.

ASSESSMENTS

To improve current practices

 

An assessment isn’t a regulatory requirement, but an accurate appraisal making it possible to improve an existing system (data integrity, risk management, qualification, infrastructure validation, document system, etc.). It includes an action/remediation plan.

SHARED/JOINT AUDITS

To reduce your costs

 

A shared/joint audit is an audit of the same supplier, performed by a subcontracted auditor on behalf of several sponsors/clients.

SPECIFIC AUDITS

To meet specific requirements

 

  • A specific audit makes it possible to meet a particular requirement:
  • CSV audit
  • Preparation for inspections (as a front or war room)
  • Structural audit (simulations)
  • Document audit (CTD/TD/Protocol and qualification/validation report)
  • For-cause audit

Our audit catalog

Preclinical Audit
Clinical audits
Regulatory Affairs Audits
Regulatory Audits of Subcontractors and Economic Operators
System and Software Supplier Audits
Quality Systems Audits
Data Integrity Audits
Mock Site Inspections
Assessments

Please contact us to get your CVO-EUROPE’s Audit Center brochure

CVO-EUROPE Audits added value

  • Audits dedicated and specific to Life Sciences industries
  • A team of expert auditors
  • Audits keeping pace with changing industries and regulations
  • Service with high added value
  • Services enhanced by our regulatory and normative intelligence provider GxpManager
  • “Tailored” services
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