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 :
Plus d'information ici.
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.
Plus d'information ici.
