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 manufacturers, contract manufacturers and laboratories for data integrity and data governance elements.
The addendum, Selection and GMP Auditing of Software and Hardware Vendors, describes a process to identify, select, and audit software and hardware vendors. The addendum contains tools to aid in the audit process. These tools include:
- Rx-360 Vendor Questionnaire- Quality Systems
- This document itemizes the Quality Management System Data Integrity aspects
- Rx-360 Vendor Questionnaire- Application Software
- This document assesses the application software for data integrity gaps
- Virtual Audit Example
- This document provides a list of suggested documents that would support a virtual audit rather than an on-site audit.
The scope for the new tools includes the manufacture and testing of human and veterinary medicinal products regulated by FDA, intermediates, active pharmaceutical ingredients (APIs), excipients and raw materials critical to product quality.
The target audience for the new Data Integrity tools is GMP auditors and stakeholders. ISPE publication, GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems (2008) should also be utilized for detailed information on computerized systems, validation and controls for data integrity.