La gestion des "raw data" électroniques au cœur des inspections BPL...
Dans cette récente mise en demeure , les autorités américaines mettent en évidence des lacunes dans la gestion sécurisée des données électroniques d'un laboratoire d'études soumis aux BPL ( 21 CFR Part 58 ) : 5. Your testing facility failed to establish standard operating procedures for data handling, storage, and retrieval [21 CFR 58.81(b)(10)]. A testing facility is required to have written SOPs for nonclinical laboratory studies that ensure consistency of procedures from study to study and from technician to technician. Without such procedures, the quality and integrity of data generated in nonclinical laboratory studies cannot be ensured. Your firm failed to establish SOPs describing the handling and retrieval of electronic data. Handling of electronic data includes the security (e.g., audit trails) and statistical analysis of raw data . Specifically, the SOP for handling electronic data should describe a procedure for the archiving of multiple statistical analy