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:
Medicinal products, veterinary drugs, combbination drugs
Our Audit and assessment services
To gain an outside perspective
An audit analyzes deviations in your system in light of new regulations and includes an audit report and observations.
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.
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.
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
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