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 its associates and other collaborating companies, and obeying the confidentiality agreements with the auditees is among the missions of the AFA Board of Directors.
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 (both associated or non-associated members)
Auditors (with the audited company and AFA)
AFA (with the audited company and the audit sponsors (both associated and non-associated members)
Sponsors (both associated and non-associated members) (with the audited company)
The following documents are established to execute the confidential disclosure agreements (CDAs):
Confidentiality agreement for each sponsor (both associated and non-associated members). A confidentiality agreement covering the information received through the audit reports shall be signed by each sponsor (both associated and non-associated members). 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.The AFA contracted auditors 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.
The Asociación Fórum Auditorías protects the confidentiality of the information received from sponsors (both associated and non-associated members) by means of the structure of the audit reports. If necessary, 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: Shared by the audit sponsors (both associated and non-associated members).
Closed part: For the exclusive use of each one of the companies.
The Asociación Fórum Auditorías will act as depositary of the audit reports and the related documentation.