All changes, made by PharmSchul users, will be documented by the additional module Audit-Trail.
The PharmSchul Audit-Trail meets the requirements of 21 CFR Part 11.

The following information will be stored in the Audit-Trail:
  • Date of adaptation
  • Time of adaptation
  • User, who performed the adaptation
  • Type of adaptation: creation, modification, deletion
  • Reason of adaptation
  • Adaptations are highlighted

The reason for adaptation needs to be entered by changing or deleting a record.

By the PharmSchul User Management an easy traceability of changes made by PharmSchul users is ensured. The display of Audit-Trail entries is also managed by the user administration.

Of course the PharmSchul Audit-Trail is validated.