Articles

Affichage des articles du juin, 2015

"Data Integrity"... suite.

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Ce fabricant d'API tchèque s'est vu signifier des manquements importants en matière de gestion des enregistrements électroniques :

2.    Failure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions. Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of (b)(4), API. Specifically, our inspection revealed your firm did not properly maintain a back-up of HPLC chromatograms that form the basis of your product release decisions... While investigating these discrepancies, our investigator requested the original electronic raw data. Your quality unit, after consulting with the Information Technology (IT) department, stated they were unable to retrieve the original electronic raw data because back-up discs were unreadable. Your quality unit then stated that back-up disks have been unreadable since at least 2013...  ... Your HPLC software lacked an audit trail…