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
MEDICAL DEVICES
MDs, IVDMDs
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
Preclinical Audit
- Preclinical Audit – Study Conduct – APC01
- Preclinical Audit – Raw Data Processing – APC02
- Preclinical Audit – Raw Data Processing – APC03
- Preclinical Audit – Trial System – APC04
Clinical audits
Clinical audits
- CRO/Study Centre/Sponsor Clinical Audit – ACL01
- Data Management/Biostatistics Clinical Audit – ACL02
- IT/IMP Manufacturer Clinical Audit – ACL03
- Laboratory Clinical Audit – ACL04
Regulatory Affairs Audits
Regulatory Affairs Audits
- Regulatory Affairs Audits – Medicinal products for human use and veterinary use – AAR01
- Regulatory Affairs Audits – Radiopharmaceutical products – AAR02
- Regulatory Affairs Audits – Foodstuffs – AAR03
- Regulatory Affairs Audits – Cosmetic products – AAR04
- Regulatory Affairs Audits – Biological products – AAR05
- Regulatory Affairs Audits – Medical devices – AAR06
- Regulatory Affairs Audits – Produits combinés – AAR07
Regulatory Audits of Subcontractors and Economic Operators
Regulatory Audits of Subcontractors and Economic Operators
- Regulatory Audit of RM and PA Suppliers – ARF01
- Regulatory Audit of Distributors, Vigilance – ARF02
- Regulatory Audit of Subcontracted Processes – ARF03
- Regulatory Audit of Service Providers (metrology, instrumentation, calibration, standardization) – ARF04
- Audit of Control/analytical Testing Laboratories – ARF05
System and Software Supplier Audits
System and Software Supplier Audits
- Production of Laboratory Equipment Supplier Audit – AFS11
- Computerized and/or Automated System Supplier Audit – AFS12
- Computerized/Automated System and Software Designer/Developer/Integrator Audit – AFS13
- SaaS/IaaS/PaaS, CS host, Data Centre, IT/Industrial infrastructure, etc. Service Provider Audit – AFS14
- Software Supplier Audit (including those considered as MDs or IVDMDs and related to connected health, mHealth, IoT) – AFS15
Quality Systems Audits
Quality Systems Audits
- Internal Quality Audit of Company Processes – ASQ41
- Audit of the Corporate Quality Management System – ASQ42
Data Integrity Audits
Data Integrity Audits
- Data Integrity Assessment – ADI43
- Mock Inspection Focusing on Data Integrity – ADI44
- Data Inegrity Audit of Third Parties – ADI45
- Computerized Systems Compliance Audit – ADI46
Mock Site Inspections
Mock Site Inspections
- Mock inspection of a drug production site – MIS21
- Mock inspection of a cosmetic production site – MIS22
- Mock inspection of a veterinary production site – MIS23
- Mock inspection of a food industry production site – MIS24
- Mock inspection of a Medical Devices production site – MIS25
- Mock inspection of a biotechnology production site – MIS26
- Mock inspection of GLP site – MIS27
Assessments
Assessments
- Assessment of QMS Practices and Procedures – EV31
- Assessment of IT Procedures and Practices – EV32
- Assessment of Practices and Procedures for Qualification/Validation (CSV, ASVà, Metrology… – EV33
- Lean 6 Sigma Assessment – EV34
- Engineering of IT Project Assessment – EV35
- Technical Assessment of Systems and Equipment (utilities etc.) – EV36
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