[COLOR=#333333]According to – Electronic Records § 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.
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But what exactly does this mean? The following article will try and clear up any misconceptions that may surround this statement.
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The Meaning of Independent
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The word independent used in relation to audit trails means once the audit trail log is generated it cannot be manipulated by operator/users of the system or anyone else for that matter.
[COLOR=#333333]The main purpose is to ensure and prove data integrity. If the data has been changed, the audit trail should record what has been changed and who made the various changes.
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The audit trail functionality should be built into the software and it should be protected and stored safely and is especially important for critical computer related processes with manual operator interaction.
[COLOR=#333333]All GxP application that strive to be Part 11 compliant must have an audit trail. Since this mimics the regulatory requirement of making correction in paper systems.
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Audit trails needs to be outside of the user’s control – running independently to capture who did what to which records, and when they did it. The expectation is that a Part 11 compliant implementation of an audit trail is automatically generated, which implies that its operation is entirely transparent to the typical end user.
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