eInfotree Access Desktop

eInfotree Access Desktop, developed by CIMCON Software, is a compliance solution designed to bring Microsoft Access databases into conformance with FDA 21 CFR Part 11 regulations. It is purpose-built for life sciences organizations operating in GxP environments where Access databases are used to manage critical data such as batch records, clinical trial data, manufacturing logs, training records, and records required by predicate rules including GCP, GMP, and GLP.

Access databases typically offer little to no built-in security, leaving data vulnerable to unauthorized modification that can compromise data integrity and regulatory compliance. Unauthorized changes in a GxP environment can result in serious consequences including improper batch release, erroneous clinical trial results, and falsification of records. eInfotree Access Desktop addresses these risks by layering robust compliance controls directly onto existing Access databases without requiring migration to a new system.

Key Benefits

• No change in user experience — databases can still be opened by simply double-clicking the file name.
• No need to relocate the database to a different storage location.
• Simple and effective remediation of Access databases for 21 CFR Part 11 compliance.
• Saves time and money by eliminating the need to migrate to a new system.
• Files continue to be saved in the native Access format.
• Quick and easy software installation with no dedicated server required.
• Easy to configure, use, and maintain.
• Automated and structured process provides confidence in database controls and process integrity to support attestation.
• Reduced validation effort through an available validation package.

Audit Trail Capabilities

• Records date, time, user ID, full user name, table name, field name, form name, action type, old value, and new value for all changes.
• Configurable reason fields allow users to document the rationale for changes.
• Fully secure and protected audit trail that cannot be tampered with.
• Tracks user logins, logouts, invalid login attempts, password changes, and account lockouts.

Electronic Signatures

• Transactions requiring electronic signatures are configurable by action type and form.
• Each e-signature captures the user ID, printed name of the signer, date, time, and e-signature meaning.
• E-signature meanings are fully configurable to meet organizational requirements.
• Signatures not performed during a single, continuous period of controlled system access require all e-signature components, in line with 21 CFR Part 11 requirements.

Security Controls

• Integrates with and enforces Access workgroup security settings.
• Enforces minimum password length and composition requirements.
• Password aging functionality forces users to create a new password after configurable intervals.
• Account lockouts are triggered after a configurable number of failed login retries.
• Loss management features allow temporary deactivation of user accounts and force a new password following an account reset.
• Automatic session timeouts protect against unauthorized access during periods of inactivity.

eInfotree Access Desktop is deployed as a desktop solution that requires no dedicated server infrastructure, making it straightforward to implement across regulated environments. CIMCON Software provides a validation package to further reduce the effort required for formal software validation, supporting organizations in achieving and maintaining compliance with FDA regulations.