eInfotree Excel Desktop

eInfotree Excel Desktop, developed by CIMCON Software, is a 21 CFR Part 11 compliance solution designed specifically for Microsoft Excel spreadsheets used in GxP-regulated environments. It is built for biopharmaceutical, pharmaceutical, and other FDA-regulated industries where spreadsheets support critical applications such as clinical trials, raw material and finished goods testing, manufacturing logs, assay testing, training records, and records required by predicate rules including GCP, GMP, and GLP.

Because spreadsheets are highly prone to errors and are widely used in regulated settings, non-compliant spreadsheet use can lead to serious consequences such as improper batch release or erroneous clinical trial results. eInfotree Excel Desktop provides a simple, effective remediation path to bring existing Excel spreadsheets into full 21 CFR Part 11 compliance without requiring migration to a new system or changes to existing user workflows.

Key Benefits

• Store and use spreadsheets directly from a SharePoint Library
• All audit trails, configurations, and settings are stored in a SQL database instance, enabling automated backup, diverse reporting, and enhanced security
• No change to user experience — spreadsheets can still be opened by simply double-clicking the file name
• No need to relocate spreadsheets to a different storage location
• Saves time and money by eliminating the need to migrate to a new system
• Quick and easy software installation with no dedicated server required
• Automated and structured processes provide confidence in spreadsheet controls and process integrity to support attestation
• Easy to configure, use, and maintain
• Reduced validation effort through an available validation package

Audit Trail Capabilities

• Tracks both user and administrator actions comprehensively
• Records date, time, user ID, full user name, cell location, action type, old value, and new value for every change
• Configurable reason field for documenting the rationale behind changes
• Fully secure and protected audit trail
• Logs user logins, logouts, and invalid login attempts

Electronic Signature Features

• Captures the user ID and printed name of the signer, the date and time the signature was executed, and the meaning associated with the signature
• Signature meanings are fully configurable to meet organizational requirements
• Signatures not performed during a single, continuous period of system access require all electronic signature components to be re-entered

Security Controls

• Configurable user accounts and password management
• Enforces minimum password length and composition requirements to ensure security and integrity
• Password aging functionality forces users to create a new password after a configurable period
• Account lockout after a configurable number of failed login retries as a transaction safeguard
• Loss management procedures allow electronic deauthorization of passwords temporarily, with mandatory password reset upon reinstatement

eInfotree Excel Desktop integrates with SharePoint and SQL databases, and is deployable enterprise-wide using a centralized server model — as demonstrated by Charles River Laboratories, which deployed the solution across 17 sites in North America and Europe with nearly 7,000 client installations. A white paper is available covering four common challenges to using GxP-compliant spreadsheets and how eInfotree addresses them.