The benefits of our audits centre
- Audits dedicated and specific to Life Sciences
- A team of expert auditors
- Audits keeping pace with changing industries and regulations
- Services with high added value
- Services enhanced by our regulatory and normative intelligence provider GxpManager
- “Tailored” services
The EPC concept
The guarantee of effective audits
Our aim is to provide audit services meeting the requirements of both the sponsors and the audited entity, making us a leader in health sector auditing.
Our vision of audits is built on three foundations: Excellence, Performance and Compliance.
EXCELLENCE
Our auditors are trained in leading audit techniques and have years of practical experience in the areas they audit.
PERFORMANCE
We tailor the audit service to the associated risks (product, process, context) at optimal cost, with effective methods and tools.
COMPLIANCE
We provide services that comply with all applicable regulatory obligations for complete auditability of your QMS.
New: a service center
Comprehensive management of your audit activities
Our audit centre can operate as a service centre for all your audit activities. With our secure data-sharing platform GxpManager, we digitize your audits:
- Scheduling the audits
- Managing the auditors’ training and accreditation
- Selecting the regulatory and normative guidelines
- Preparing standard questionnaires for the audits
- Analyzing the responses’ compliance
- Managing the observations
- Managing CAPA
- Producing reports
- Email alerts
- Multiple sites
- Rights management
Audit tools
A tool to perform effective audits
The GxpManager Audit application is a powerful tool used by the CVO-EUROPE audit teams. Information is consolidated, traced and used reliably and effectively, boosting the audit quality. It improves existing working methods whilst retaining the simplicity of office tools. At the end of the service, you can build on the experience gained during the audit and choose to adopt the app, subscribe to GxpManager and enjoy a preferential rate for transferring the CVO-EUROPE audit data.
Our system
An effective system
- We have our own QMS
- We have our own electronic database
- We have our own procedures and records
- We can offer you our own formats (audit programs, audit plans, audit reports, CAPA follow-up)