Overview
Welcome to the Audit Operations Group
The Audit Operations Group provides guidance on all aspects of the Rx-360 Audit Program. The Group routinely discusses topics and best practices associated with pharmaceutical auditing.
If you are interested in joining this group, please contact Jaye Greene at jgreene@rx-360.org.
Meet The Board: Kate Silva, MilliporeSigma
Kate Silva is the Head of Quality Management Systems and Audits for MilliporeSigma. In this role, she is responsible for overseeing the global life science framework for compliance with quality, regulatory, and industry standards. Kate […]
Meet The Board: Bill Campagna, Eli Lilly and Company
Bill Campagna is the Senior Director of Quality for Procurement and Operations for Eli Lilly and Company; and he’s passionate about serving on Rx-360’s Board of Directors. “I’m proud to be part of Rx-360’s Board […]
Remote Auditing Library
Remote Auditing Library
Remote auditing during the coronavirus pandemic of 2019 and 2020 has grown in its utility within the pharmaceutical industry. The processes involved with a remote audit will continue to evolve as the industry continues to adopt best practices. Being able to understand the growing bandwidth issues on both the pharmaceutical supplier side and the manufacturer side will position remote auditing to continue its growth and utilization for the long term.
Rx-360, through our Member Consortium, has developed this library of resources to outline and share best practices that the Rx-360 membership have utilized and observed as well as processes that have been incorporated into the Rx-360 Audit Program.
rx-360 Remote audit best practice guide
This foundational guide will focus on definition of terms, types of remote auditing, IT capability, pre-audit surveying and a decision tree around deciding on a remote audit versus an onsite audit.
REMOTE AUDITING – A SUPPLIER PERSPECTIVE
This paper focuses on supplier audits and how remote audits impact the supplier. The perspective of the supplier with respect to remote audits is an important piece of the puzzle as to what the supplier audit landscape will look like in the future, even beyond the COVID-19 pandemic.
REMOTE AUDITING TECHNOLOGY BEST PRACTICES AND SOLUTIONS
For years the standard way to perform audits was to go to the facility or location where the activity to be audited took place. As computer systems and related technology developed, the ability to look at evidence remotely came into existence. This paper provides an overview of the best practices and solutions shared by our Member Consortium.