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 recording any changes to the data, including: previous entries, who made changes, and when changes were made. During the inspection, we also noted that all laboratory employees shared a common log-in and password to access the system...In your response to this letter, provide a comprehensive corrective action plan for computer system controls over all laboratory and manufacturing instrumentation and equipment. This response should include but not be limited to:
Information regarding changes in the reliability of your information technology infrastructure, including but not limited to improved computer systems, systems validation, revised procedures, and appropriate retraining of employees that will be implemented immediately to ensure your firm creates and retains complete and accurate electronic raw data.
Your firm's procedure for the establishment, issuance, and control of passwords used to access your analytical instrumentation. All access levels for computerized systems should be clearly defined and documented in a written procedure.
A detailed summary of the steps taken to train your personnel on the proper use of computerized systems.
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