Area of expertise
Human and Veterinary Drug
- Good PharmacoVigilance Practices
- Good Practices Clinical
- Good Distribution Practices
- Promotional Information
- Good Medical Devices VIgilances Practices
- Quality Management System (ISO 13485)
Auditing is a key tool for verifying compliance with requirements and ensuring continuous improvement, the basic principle of all efficient quality systems.
Rich in many years of experience in the realization of systems audits, both at the level of parent companies, subsidiaries, distributors and partners, AUDITHEM offers its expertise in the implementation of audits.
The audits are carried out according to the methodology adopted by the authorities during the inspections. They are not only tools for monitoring compliance and improving processes, but also a mean of preparing the organisation for inspections carried out by the authorities.
Each of the key processes is evaluated on the basis of the information gathered from the audited organization, the documentation available, such as the procedures, working instructions and corresponding records and the review of practical cases. Thus, the main objectives are to check whether appropriate measures are in place for each process, and whether they are properly and systematically implemented and documented in accordance with the requirements.
AUDITHEM is able to accompany its customers throughout the process, or according to its needs at one or more stages of the audit process.