est à nouveau au cœur des remarques de cette nouvelle mise en demeure de l'agence américaine ; les deux citations pointent des défaillances au niveau de la sécurité et de l'authenticité des enregistrements : Failure to protect computerized data from unauthorized access or changes. Our inspection found that there were no restrictions to access the laboratory data residing on the workstations attached to your standalone instrumentation: (b)(4) High Pressure Liquid Chromatographs (HPLCs), the Fourier Transform Infrared Spectrophotometer (FTIR), the gas chromatograph (GC) and the drives and portable media used as back-ups. There was no protection of the data from alteration and deletion and no audit trails to detect if such alteration or deletion had occurred . You have stated that you are in the process of purchasing and updating software to handle these problems. You have also stated that there had been no misconduct by laboratory personnel. However, our investi