Over the past 16 years, Vigilex has built a sound reputation in pharmacovigilance audits for pharmaceutical companies. Senior Vigilex staff are regularly involved in individual audits as well as audit cycles worldwide.Vigilex typically conducts broad PV system audits involving a variety of functions relevant to PV within the organisation, but has also substantial experience in audits of specific activities like PSURs and handling 3rd party agreements.The audit methodology employed by Vigilex is very similar to the approach taken by competent authorities and ensures that clients are well prepared for inspection by these authorities. Audits can be conducted on site and/ or on distance. Furthermore, Vigilex offers PV "certificates" for organisations offering marketing and sales activities for pharmaceutical companies ensuring their capabilities to adhere to basic PV principles such as a QMS and PV basic knowledge.
Vigilex has gained audit expertise in the following geographical areas: The Far East, Japan included, South America, USA and most of the Western European countries.
Further background information on Vigilex audit experience