Guide to Investigations – A Collaborative Publication by the Rx-360 Latin America Working Group 

This is a collaborative publication by the Rx-360 Latin America Working Group 

Translated into three languages, the purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This guide will support continuous improvement processes and reduce the cost of nonconformity, avoiding recurrence. A robust investigation will determine the root cause of a nonconformity. The establishment of proper corrections and corrective actions, which address the root cause, shall prevent a recurrence of the nonconformity.

When you download this publication, you will download a zipped folder. This folder will include an English, Spanish and Portuguese translation of the publication. As well as three translated versions of the Fillable PDF Annex that was developed as well.