eInfotree Access Module

The eInfotree Access Module is designed to ensure that Access databases used in critical GxP applications are compliant with FDA 21 CFR Part 11 regulations. It addresses the typically low security of Access databases, which makes them susceptible to unauthorized changes that can compromise data integrity and compliance. This module is critical for maintaining the integrity of batch, clinical trial, raw material, manufacturing logs, assay test data, and other GxP-related records, preventing potential serious consequences from data alteration.

Benefits:

• No change to user experience; databases are accessible by simply double-clicking the file name.
• Eliminates the need to relocate databases to achieve compliance.
• Offers a cost-efficient solution by avoiding the migration to new systems.
• Databases continue to be saved in their native Access format.
• Quick and simple software installation without requiring a dedicated server.
• Includes a validation package for reduced validation efforts.

This module provides a structured and automated process, enhancing confidence in database control and integrity. It is also easy to configure, use, and maintain.

Features:

Audit Trail

The module logs comprehensive audit details such as date, time, user ID, full user name, table name, and action type. Additionally, it records old and new values, along with configurable reason fields for changes. The audit trail also includes user logins, logouts, invalid attempts, password changes, and account lockouts, ensuring full security and protection.

Electronic Signatures

It enables transactions requiring electronic signatures to be configured by action type and form. The module captures the user ID, printed name, date, time, and e-signature meaning, which are configurable. It also ensures compliance for signatures not executed during a single session by requiring all signature components in a controlled manner.

Security

The eInfotree Access Module enforces robust security measures integrating with Access workgroup security. It mandates strong password policies including minimum length and composition, and forces periodic password updates. The tool provides loss management features allowing temporary deactivation of user accounts, and mandatory password resets after inactivity or reset. Additional safeguards such as configurable account lockouts and automatic session timeouts enhance security further.