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...maintains a computer-generated audit trail with each file stored on the virtual BM-Windream drive. Components of each entry are a validated date and time stamp, name of user and the type of change that was made on the file. The following actions are automatically tracked:
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Creating a file
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Changing file contents or index field contents
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Assigning a file to a document type
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Changes in access privileges to the file
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Check-out and Check-in
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Versioning
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User comments
The comment function of the audit trail allows users to enter the reason for a change or the status of a document like an SOP. User entries cannot be changed or deleted after they are submitted. The audit trail complies to the requirements of 21 CFR part 11.
For each version of a file or document, an individual audit trail is maintained. Versions and audit trails of each file are sequentially linked, so that the entire history of a file can be retrieved and reviewed with a mouse click directly in the Windows® Explorer.
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