Establishes data integrity programs with quality systems Data integrity compliance enables organizations to use electronic data when making GMP decisions. This program ensures compliance with Part 11 and Annex 11 (EU) regulations.

Computerized system validation program stand up GAMP-based CSV programs ensure standardized computer system implementations, maintaining the compliant state throughout the system lifecycle.

Conducts mock data integrity and computerized systems audits Mock audits identify potential gaps and assess effectiveness of quality programs, which are a practical tool that drive audit readiness.

Establishes computerized system vendor audit program All computerized systems that automate GMP business processes require thorough vendor auditing to ensure they meet software development standards.