eInfotree

eInfotree is a software solution designed by CIMCON Software to provide 21 CFR Part 11 compliance for spreadsheets used in support of critical GxP applications. According to the vendor, this tool aims to ensure data integrity, accuracy, and security in industries regulated by the FDA. It is targeted at small to large-sized companies operating in FDA-regulated industries, including pharmaceutical, biotechnology, medical device, and clinical research organizations. Professionals such as Quality Assurance/Quality Control professionals, Regulatory Affairs professionals, Compliance officers, Laboratory managers, and Research and development teams are said to benefit from eInfotree's robust features.

Key Features

Audit Trail: According to the vendor, eInfotree tracks both user and administrator actions in GxP spreadsheets. It records information such as date, time, user ID, full user name, cell location, action type, old value, new value, and provides a configurable reason field for documenting the purpose of changes.

Electronic-Signatures: The vendor states that eInfotree seamlessly integrates electronic signatures into the spreadsheet workflow. It includes the user ID and printed name of the signer, along with the date and time the signature was executed. The meanings of e-signatures can be configured based on different types of approvals.

Security: eInfotree allows the configuration of users and passwords to ensure controlled access to spreadsheets. According to the vendor, it enforces password security measures such as minimum length and composition, password aging, and account lockout after a configurable number of retries. The software also provides loss management procedures to temporarily deauthorize passwords and require a new password after reset.

Store and Use Spreadsheets from a SharePoint Library: Users can store spreadsheets in a SharePoint library using eInfotree, according to the vendor. This feature enables centralized access and management, allowing users to open and use spreadsheets directly from the SharePoint library without the need to move them to a different location.

Automated Backup and Reporting with SQL DB: eInfotree stores audit trails, configurations, and settings into an instance of SQL DB for automated backup and enhanced security, says the vendor. It offers diverse reporting capabilities based on the stored data, facilitating analysis and compliance purposes. This feature ensures data integrity and recoverability in case of system failures or data loss.

No Change in User Experience: According to the vendor, eInfotree ensures that users can continue to open spreadsheets the same way by simply double-clicking the file name. They can work with spreadsheets using familiar interfaces and functionalities without any disruption or retraining.

Simple and Effective Remediation for Compliance: The vendor claims that eInfotree streamlines the process of achieving 21 CFR Part 11 compliance for Excel spreadsheets. It facilitates easy and efficient remediation by implementing necessary controls and features without significant manual effort.

Time and Cost Savings: According to the vendor, eInfotree eliminates the need to migrate to a new system, saving time and money. Its quick and easy installation process, along with minimal setup requirements, ensures a hassle-free experience. Additionally, the software reduces validation effort with an available validation package, providing an automated and structured process to boost confidence in spreadsheet controls and process integrity.

Easy Configuration, Use, and Maintenance: eInfotree offers a user-friendly interface for simple configuration of settings and user access controls, according to the vendor. Both administrators and end-users can easily navigate the software without extensive technical expertise. The software requires minimal ongoing maintenance, ensuring smooth and hassle-free operation.

No Dedicated Server Required: The vendor states that eInfotree operates without the need for a dedicated server, saving infrastructure costs. It can be deployed in existing IT environments without additional hardware requirements, making it a convenient choice for organizations.