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21 CFR PART 11 COMPLIANCE The Intelex System includes dual-signature functionality for organizations required to meet Title 21 CFR Part 11. In the digital age, electronic records and signatures have made paper documents and hand-written signatures an increasingly rare occurrence. To address this shift in standard business procedures, the US Code of Regulations instituted Title 21 CFR Part 11 which legitimizes electronic records and signatures by clearly defining the criteria under which an electronic record or signature can be accepted as valid. Industries most commonly affected by Title 21 CFR Part 11 typically fall under the regulatory standards established by the USA Food and Drug Administration. To help our clients achieve Title 21 CFR Part 11 compliance, Intelex has added dual signature functionality. This means that Intelex Users can assign dual-signature authorization requirements to their critical business records. Required Dual Signatures The Intelex System has been designed to enable end users to require dual-signature authorization on critical business records. Secure Authentication & Security of User Access The Intelex system features a robust security system that enables administrators to control access to all the locations, features, and data held within the system. This ensures that only certain personnel have access to the records that are appropriate for them to view. Context Sensitive Screen Control Security can also be controlled throughout the workflow and approvals process. Specifically, when data is submitted into the system, an administrator can define the mandatory sign-offs required prior to the data being submitted. In addition, administrators can also configure the security for each stage of the process to control whether data is read-only or editable, whether the user can request additional information, or if their sign-off is required. In instances where sign-off is required, the security ensures only the responsible user has access to the sign-off features. Document Access Log The Intelex system automatically records an audit trail of all users who have accessed a document. This enables administrators to view the entire viewing history for each document. This log can be generated as a PDF report. Audit Trail on Record Access The Intelex system contains an audit trail feature that captures and records all user modifications on records. This audit trail functionality records all changes and updates (no matter how minor) and maintains a history of user names, IP addresses, and date/time stamps. Viewable History of Revisions of Records In addition to maintaining an audit trail of record changes, the Intelex system also maintains a history of revisions for each record. This enables administrators to not only see who made the changes, but also to view details on the changes that were made. The system even enables administrators to compare the old version of the record side-by-side with the new version so that all record changes are retained and fully auditable.
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