Publications

Remote Auditing Technology Best Practices and Solutions

January 11, 2021

Auditing to verify a process or system meet stated criteria.  The audit process involves looking for objective evidence that will substantiate that the process or system under review meets the objectives of the quality management […]

Publications

Remote Auditing – A Supplier Perspective

December 8, 2020

Although remote auditing has been in existence for quite a while the practice has become more prevalent and expanded with the recent onset of COVID-19. With public health or other emergencies that could cause risk […]

Publications

Rx-360 Remote Audit Best Practice Guide

August 28, 2020

Rx-360 through our Member Consortium has developed a Version 1.0 Best Practice Guide for Remote Auditing. This initial version will present a foundation on best practices that the Rx-360 membership have utilized and observed as […]

Publications

Selection and GMP Auditing of Software and Hardware Vendors

October 7, 2019

The Data Integrity Working Group of Rx-360 members has generated an addendum to the previously issued GMP Audit Manual, Data Governance and Data Integrity which provided an approach for GMP auditing and self-assessment of pharmaceutical […]

Publications

Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process

December 5, 2017

The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite of their Supplier Management Programs. Suppliers as well are being asked to host more customer […]