Deux "Warning Letters" insistent sur la gestion des enregistrements électroniques
Ces deux mises en demeure mettent en évidence des manquements importants dans l'intégrité des enregistrements de laboratoire : 2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). QC personnel created unauthorized folders on laboratory computerized systems without appropriate oversigh t... As part of your comprehensive evaluation and risk assessment, include a detailed description of all computerized systems in your facility used for testing drugs. This description should include information on each electronic folder that was not created pursuant to a valid SOP and an assessment of every file in each such folde r, including information about the sample (product), date of test, lot number and original test result over the last five (5) years, except for data relating to exhibit batches, in which ca...
