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PharmSchul
Audit-Trail
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
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Time of adaptation
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User, who performed the adaptation
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Type of adaptation: creation, modification, deletion
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Reason of adaptation
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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.
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