CFR Gateway

CFR Gateway is a compliance software layer developed by Agaram Technologies that enforces 21 CFR Part 11 (FDA) and EudraLex Annex 11 (EU/UK) requirements on any laboratory instrument or software application — including legacy and non-compliant systems — without requiring replacement or modification of existing setups. It is designed for pharmaceutical, biotech, and life sciences laboratories operating in regulated environments across multiple geographies, including those subject to MHRA oversight in the UK.

By loading at system startup and acting as a controlled gateway, CFR Gateway wraps around existing PC-based instrument software and enforces the full suite of data integrity controls mandated under both regulatory frameworks. This approach eliminates the significant cost and time associated with replacing non-compliant instruments, which can run to tens of thousands of dollars and take months to execute.

Core Compliance Capabilities

• Role-Based Access Control: Administrators can assign and restrict access to specific applications and data according to user roles, ensuring only authorised personnel can view or interact with sensitive information.
• Automated Audit Trail: Once launched at startup, CFR Gateway continuously monitors and records comprehensive, date- and time-stamped audit trails covering user logins, logoffs, data creation, and all modifications — stored automatically in a tamper-proof secure server repository.
• Electronic Signatures: Supports electronic signature requirements as mandated under 21 CFR Part 11 and Annex 11.
• Secure Server Storage: All lab data is automatically transferred to a central secure server, preventing local storage on user PCs and maintaining a single source of truth.
• Version Control: Every file is versioned upon modification, preventing accidental or intentional overwriting of records.

Data Integrity Framework (ALCOA+ Aligned)

• Authenticated user login is required at system startup before any application can be accessed.
• Role-based access control restricts application and data access to authorised users only.
• Every user action is captured in an immutable, timestamped audit trail on a secure server.
• All files are subject to version control to preserve record integrity.
• No data can be stored locally; all records are automatically centralised on the secure server.

Compatibility and Supported Applications

• Works with any PC-based laboratory software or instrument application running on Windows.
• Compatible with standalone instrument software, chromatography data systems, spectroscopy tools, and standard desktop applications such as Microsoft Excel used in lab workflows.
• Operates at the operating system level, making it independent of instrument make, manufacturer, or software version.
• Functions as a universal compliance solution for mixed instrument environments, including legacy systems running older, non-compliant software.

Key Benefits for Regulated Labs

• Brings non-compliant and legacy lab instruments into full 21 CFR Part 11 compliance without replacing hardware or proprietary software.
• Satisfies both FDA and EMA regulatory requirements, making it suitable for labs operating across US, EU, and UK jurisdictions.
• Ensures labs are audit-ready at all times through continuous, automated compliance monitoring.
• Significantly reduces the cost and time required to achieve regulatory compliance compared to instrument replacement.
• Adopted by leading pharmaceutical and life sciences laboratories.

CFR Gateway is a server-based solution that centralises all data storage and audit records, ensuring no compliance-critical information resides on local workstations. It is part of Agaram Technologies' broader portfolio of laboratory informatics products, which includes Qualis LIMS, Logilab SDMS, Logilab ELN, and other solutions for regulated laboratory environments.