Data Integrity for Chromatographic Systems

This training provides a specialized focus on data integrity requirements for chromatographic systems (HPLC, GC, UPLC, IC, etc.) used in GMP-regulated quality control laboratories. It aligns with FDA 21 CFR Part 11, EU GMP Annex 11, WHO TRS 996 Annex 5, MHRA GxP Data Integrity Guidance, and PIC/S PI 041, emphasizing ALCOA+ principles for electronic and hybrid data. Participants will learn how to ensure compliance in chromatography data acquisition, processing, review, approval, and storage — with a focus on preventing data manipulation, ensuring secure audit trails, and maintaining traceability from raw data to final reports.