Audit

EXTERNAL AUDIT PART TWO AND THREE

The audit is a systematic, independent and documented process to obtain evidence and objectively evaluate to which extent the criteria has been met.
The audit is based on six principles: integrity, impartial presentation, necessary professionalism, confidentiality, independence and evidence-based approach.
Part two audit: conducted for an organization that has an interest in evaluating that other subjects (suppliers) maintain specific product and service quality standards (UNI EN ISO 19011:2012 3.1).
Part three audit: carried out by independent audit organizations, authorities which in the legislation or organization fields provide certifications (UNI EN ISO 19011:2012 3.1).

  • AUDIT Data Protection

The auditing activity assesses if and to what extent the processes, operating procedures, services and facilities are compliant with the regulations of the “Data Protection” laws and the new Community Regulations.
The audit can cover all stages of these elements and will evaluate the state of compliance of the adopted processes.
The audits can cover the Pharmaceutical and Health organization’s processes and procedures (Part three audit) or those of their suppliers/providers (Part two audit).

  • AUDIT “Guidelines for the processing of personal data in the field of clinical trials of pharmaceutical drugs”

The audits are conducted to evaluate the compliance and the respect of what expressed and contained in the Guidelines issued by the Italian Data Protection Authority for the protection of personal data of 24 July 2008 (web document 1533155).
The auditing activities are used to evaluate the processes of collection, circulation, storage of multiple information regarding the health, and in some cases the sex life of the person involved in the clinical trial and that present various critical aspects in reference to the protection of personal data and therefore require the adoption of high precautions to prevent specific risks for the parties involved.

The studies are carried out at the institutions and the hospitals authorized by law and are identified by the Sponsor. The Clinical Monitors are subjects, external to the company that can also be outside the EU territory; the information relative to the subjects and their relative biological samples may have an extremely complex flow for which it is imperative to verify the safety aspects.