CFR 21 part 11

Meet the 21 CFR Part11 FDA requirements

Audit Trail

The 21 CFR Part 11 directive requires and standardizes coherent process documentation if it is available in fully or partially electronic form. The log file is saved in non-changeable binary format and can be checked using an Audit Trail Viewer.

Meet the requirements of the audit trail:

• • Time and date of the value change

  • Project ID, PC and database name

  • Old and new value

  • User name

  • Event/function

  • Comment/reason for change