Online Software Help Manual

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Audit trail

What is an audit trail?

Following the guide lines of the Food and Drug Association (FDA), the software includes an audit trail for all objects, that can be modified, according to the CFR 21 part 11 guide lines. An audit trail is a list of all modifications of an object. It shows the complete history of an object from the point of creation until now and all things happened meanwhile. Every modification will cause an entry in the audit trail of the object, containing detailed information about modification properties, respectively. The audit trail of an object can be reviewed in the audit trail tab.

What information is logged in an audit trail?

The following information is logged:

  • The real name of the user, who modified the object.

  • The department, the user belongs to indicating his actual function in the company he works.

  • Date and time of modification of the object.

  • Modification details
    This is meant to be a detailed description of parameters of the respective modification.

Which actions in the software will cause an audit trail entry?

In principle, all operations, that modify the object permanently, will cause an audit trail entry.

The following actions will be logged:

  • Any mathematic function applied to an object.

  • Importing and exporting an object.

  • Renaming objects