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Secure and Accurate Electronic Records

BarTender ensures the integrity of electronic records through its robust data management capabilities. It allows for secure creation, modification, and storage of electronic records ensuring that they are accurate, complete, and reproducible in a legible format. BarTender incorporates advanced data validation checks and real-time monitoring to ensure data accuracy and compliance.

Robust Electronic Signatures

BarTender supports the use of electronic signatures and ensures that these signatures are uniquely attributable to a single individual, providing non-repudiation and ensuring that signatures cannot be easily falsified. BarTender also incorporates mechanisms for signing records, including password-protected access and multi-factor authentication.

Comprehensive Validation Process

BarTender’s validation process includes thorough testing and documentation to meet its intended use and regulatory requirements. BarTender provides tools and templates to help companies document their validation efforts, making it easier to demonstrate compliance.

Advanced Audit Trail Capabilities

BarTender includes built-in audit trail features that automatically capture and store detailed logs of all user actions related to electronic records. These audit trails are secure, time-stamped, and tamper-evident, providing a transparent and traceable record of all modifications, deletions, and access to records. This functionality is critical for maintaining compliance with FDA requirements and for conducting internal audits or investigations.

Enhanced Security and User Access Management

Implement stringent security measures to control user access and protect electronic records from unauthorized access or alterations. This includes role-based access control where users are assigned specific roles and permissions based on their responsibilities. BarTender also supports encryption and secure login protocols to further safeguard data integrity and confidentiality allowing for only authorized personnel to access and manage critical labeling information.

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