Confidentiality

Confidentiality constitutes one of the key agreements that should be established for the correct development of the Asociación Fórum Auditorías (AFA) activities.

Preserving the confidentiality of the information provided by AFA’s associates and customers and other collaborating companies, and obeying the confidentiality agreements with the auditees is among the main missions of AFA’s Board of Directors.

The information considered as “Confidential” is:

  • Relation sponsor – audited company
  • Information provided by audit sponsors
  • Information collected during the audit related to the audited company and their processes
  • Audit reports

Confidential Disclosure Agreements (CDAs) among the four parties involved in the audits should be established:

  • Audited companies (with the auditors, AFA and the audit sponsors)
  • Auditors (with the audited company and AFA)
  • AFA (with the audited company and the audit sponsors)
  • Sponsors (with the audited company)

The following documents are established to execute the confidential disclosure agreements (CDAs):

  • Confidentiality agreement for each sponsor. A confidentiality agreement covering the information received through the audit reports shall be signed by each sponsor . The use of this information shall be restricted to the process of suppliers’ validation and as supporting evidence in front of the Health Authorities or potential clients. In case of a corporation and, unless otherwise indicated in the corresponding CDA with the audited company, the report could be used by the other affiliates for the same purpose.
    AFA, represented by its Board of Directors, is committed not to disclose the information received from the sponsors on what the active substances, related products, observations, complaints or related projects refers to. AFA shall establish the necessary mechanisms to comply with this requirement. This information will be solely used for conducting the audit.
  • Confidentiality agreement for the auditors. Auditors contracted by AFA shall sign a confidentiality agreement covering the information received during the preparation and development of the audit:
    • · Information received from each sponsor involved in the audit.
    • · Information collected during the audit, which shall be entirely delivered to the Association.
    • · The Audit report that, once issued, is property of the Asociación Fórum Auditorías.
  • Confidentiality agreement with the audited companies. Confidentiality agreement of the Asociación Fórum Auditorías in relation to the audited companies regarding the audit reports.

Asociación Fórum Auditorías protects the confidentiality of the information received from sponsors by means of the structure of the audit reports. Reports are divided in a common part related to general GMP aspects, such as organization, documentation, facilities, laboratories, warehouses, etc; and an specific part associated to a product or products, for each company, typically including contractual aspects, specifications, process validations, complaints, analytical methods, DMF, etc. The results of the audit will be documented in separated reports for each company where both parts are included:

  • Open part: Common for all audit sponsors
  • Closed part: For the exclusive use of each one of the companies

Asociación Fórum Auditorías will act as depositary of the audit reports and the related documentation.