La MHRA publie son rapport annuel des tendances d'inspections

Dans ce rapport, on trouve notamment les observations se rapportant à l'annexe 11 des BPF :


Avec les observations mentionnées suivantes :

Deficiencies related to data backup: 
  • Following a software update, data was lost from an autoclave control system.
  • The system backup was unable to recover lost data as the backup was only performed on a 3 monthly basis.
  • The backup CD/DVD for the autoclave control system was not stored within a controlled environment to assure its integrity. 
  • Data from the integrity test was not backed up. The system was observed to overwrite previous data. 
  • Backups were required to be reviewed for accessibility annually for 5 years however this failed to ensure that data that is required to be stored for longer such as validation data, was accessible for its full retention period. 
  • Backups were permitted to be made on the same computer drive which failed to ensure that a separate copy was available following drive failure or corruption. 

Deficiencies related to inadequate control of computerised systems: 
  • Access to files and the system clock on the hard drive were available to all users. 
  • The lock screen used a shared password. If a user had logged into the software behind the lock screen and another user opened the computer, they could perform actions under the initial user’s login.
  • Users had more authorisation on the chromatography data system than was permitted according to the SOP.
  • Access control systems were not considered GMP systems despite their intended purpose to control access to GMP areas. 
The HPLC software within the laboratory was not configured for GMP Compliance: 
  • Unique user passwords were not enforced. 
  • Users were permitted to change the default audit trail. 
  • Users were permitted to change the default “require user comments”. 
  • Users were permitted to copy non related projects. 
  • Users were permitted to use annotation tools. 

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