Selection and GMP Auditing of Software and Hardware Vendors
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 […]
Remote Auditing Library
Rx-360 Town Hall Series Learn About the Rx-360 Audit Program
Remote Auditing Technology Best Practices and Solutions
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 […]
Remote Auditing – A Supplier Perspective
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 […]
Rx-360 Remote Audit Best Practice Guide
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 […]
Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process
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 […]