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eInfotree Excel Plug-In 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Excel Module
Compliance

eInfotree Excel Module
Implementation

Client Responsibilities

When used with the full eInfotree Digital Compliance solution, the following additional features are available:

Ability to restrict user privileges by file. For example, users may only have access privileges to specific Excel files.

Ability to define multiple levels of privileges.
 

11.10(e)

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

The eInfotree Excel Module contains a secure, computer-generated, time-stamped audit trail to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

Recorded fields include date, time, user ID, full user name, worksheet modified, cell location, action type, old value and new value.

The audit trail records are stored in an Excel worksheet within the same Excel file.

The audit trail is protected and cannot be altered by users.

Excel functions where an audit trail cannot be provided due to system limitations are disabled.

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