• Audit supports the user in meeting special quality requirements, e.g.
  • Production plant requiring validation according to 21 CFR Part 11 FDA ¹⁾
  • In respect of traceability according to EU 175/2002 ²⁾
• The entries in the audit trail are uniquely assigned to users. This means that responsibilities are clearly identifiable.
• The audit trail, stored as a CSV file ³⁾, can be checked via a security mechanism to find out if subsequent changes have been made.
• For particularly important user actions, e.g., starting production or loading new recipes, electronic signatures and comments can be configured and then called up and logged during runtime.

1) The FDA (Food and Drug Administration) is the American public health body

2) 21 CFR Part 11- law on plant validation

3) CSV Comma Separated Values