Publications

Selection and GMP Auditing of Software and Hardware Vendors

December 7, 2022

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 […]

Rx-360 Insights

Meet The Board: Kate Silva, MilliporeSigma

June 15, 2022

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 […]

Rx-360 Insights

Meet The Board: Bill Campagna, Eli Lilly and Company

May 9, 2022

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 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 […]