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 analyses of the clinical pathology raw data with the study records. For Study (b)(4), multiple sets of statistical analyses were maintained on the firm’s electronic server, and were not archived appropriately.

During the inspection, you failed to provide the FDA Investigator with any procedures related to raw data received for statistical analysis.  Furthermore, your facility does not have a defined process for saving and archiving electronic data.  Although you provided the FDA Investigator with SOP H-31, “Server” and “Data Storage and Disaster Recovery,” which describes the physical storage of electronic data in a central file server, your SOP lacks details concerning how you ensure the security of data, and how changes to the files are managed and documented. Furthermore, you failed to monitor access and record changes (via an audit trail) of electronic statistical data and statistical analyses. Thus, the quality and integrity of your data and analyses cannot be ensured.

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