eInfotree Excel Module

The eInfotree Excel Module offers a solution for ensuring spreadsheets are compliant with 21 CFR Part 11 regulations, important for industries such as biopharmaceutical and pharmaceutical where FDA regulations are critical. Spreadsheets support crucial GxP applications, including clinical trials, testing, and manufacturing logs, where data accuracy and integrity are paramount.

Due to the common use of spreadsheets and their proneness to error, they require stringent validation to avoid serious consequences. The eInfotree Excel Module simplifies compliance by storing spreadsheets in a SharePoint Library and maintaining all audit trails, configurations, and settings in a SQL database, enhancing security and automation without changing the user experience.

Benefits

• Allows spreadsheets to be used and stored in their original location, with no need for migration.
• Saves time and costs by retaining existing systems.
• Automates validation through a packaged validation solution, reducing effort.
• Enhances spreadsheet controls and process confidence for trustworthy attestation.

Features

Audit Trail

• Monitors actions by users and administrators, recording specifics such as date, time, user ID, and cell alterations.
• Includes secure auditing of user logins, logouts, and unauthorized access attempts.

Electronic-Signatures

• Complies with regulatory standards by embedding user ID, full name, signature date and time, and customizable meanings with each e-signature.

Security

• Facilitates user and password configurations, enforcing comprehensive password rules for security.
• Incorporates password aging policies and account lockouts, enhancing transactional integrity.

The system's capabilities greatly assist organizations in reducing human error and maintaining data integrity, as seen in its success at Charles River Labs, where eInfotree has been implemented across 17 sites, supporting digital transformation and cost efficiency by automating compliance processes.