Security Settings
- Only administrators have access rights to these settings.
Not all of the tools provided by LHC Secure must be engaged to be 21 CFR Part 11 compliant. System administrators can choose which options to implement. By default all options are enabled, except Email Alerts which require customization to function, e.g., connecting to your email server.
Select System>Security>Settings:
An integral part of compliance, review the controls that ensure user authentication. |
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Every user must have a secure User Account. |
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LHC's event notification feature; (not a requirement for compliance ). |
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Turns on/off an audit trail event prompt, a comment form to collect the user's explanations or descriptions of the changes they made. |
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When enabled, creates a Protocol History folder in the protocol's source file folder and saves a copy of the original or pre-change protocol there. |