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CFR Gateway: 21 CFR Part 11 & Annex 11 Compliance for Non-Compliant Lab Instruments

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Discover the power of CFR Gateway

Transform & empower your non-compliant systems & instruments into compliant powerhouses

Make your Non-compliant systems & Instruments Compliant

Enable Authorised Access for Applications and Data

    CFR Gateway features a role-based authorization system that enables administrators to assign and restrict access to data according to user roles

  • Controlled Access

    • Ensure that only authorized users can view specific applications

  • No Data Breach

    • Secure sensitive information and enable controlled access to data

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Unleash your lab’s data integrity & compliance potential

    Once launched during startup, CFR Gateway constantly monitors & maintains comprehensive date & time-stamped audit trail

  • Track User Activity

    • Maintain comprehensive records of when users access and exit the system through user login & logoff details

  • Ensure Traceability

    • Automatically track user modifications and changes to data, ensuring accountability

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Safeguard your lab data & information

    CFR Gateway protects & transfers your lab data to a secure server for uncompromised protection

  • Version Control

    • All data is versioned in the event of modifications made

  • Secured File Access

    • No access to files on the local PC, users can only download files from server

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CFR Gateway fortifies compliance, and protects the integrity of your system

Achieve impeccable data integrity and compliance with CFR Gateway. Safeguarding your data from inception to storage, ensures 100% integrity across instrument software and standard desktop applications. Users authenticate through the gateway at system startup, granting authorized access to applications

Every action is meticulously tracked, creating a comprehensive audit trail automatically stored in a secure server repository

Adopted by Leading Pharma & Life Science Labs

Safeguard data integrity with CFR Gateway, turn legacy and non-compliant instruments into compliant, controlled, and audit-ready systems

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Inventia Healthcare Limited
Biocon Biologics
Moderna
Cipla
Aarti Pharmalabs Ltd
Lonza

Frequently Asked Questions

CFR Gateway is a compliance layer developed by Agaram Technologies that enforces 21 CFR Part 11 and EudraLex Annex 11 compliance on any laboratory instrument or software application including legacy and non-compliant systems without requiring you to replace or modify your existing setup. It loads at system startup and acts as a controlled gateway through which users must authenticate before accessing any application. Every user action, data modification, and file access is automatically tracked and stored in a secure, tamper-proof server repository, making your lab audit-ready at all times. Download CFR Gateway Brochure

Yes. CFR Gateway is specifically designed to bring non-compliant and legacy lab instruments into full 21 CFR Part 11 compliance without replacing the instrument or its software. It wraps around any existing PC-based instrument software and enforces role-based access control, immutable audit trails with date and time stamps, electronic signatures, and secure server storage — all of which are mandated under 21 CFR Part 11. This means even instruments running older, non-compliant software can operate within a fully regulated, audit-ready environment.Contact Sales for A Personalized Demo

Yes. CFR Gateway is fully aligned with both FDA 21 CFR Part 11 (US) and EudraLex Annex 11 (EU/UK) requirements for electronic records and electronic signatures in regulated pharmaceutical environments. This makes it suitable for pharmaceutical, biotech, and life sciences labs operating across multiple geographies, including those subject to MHRA oversight in the UK. The system enforces the same core data integrity controls — audit trails, access control, version control, and secure data storage — that both regulatory frameworks mandate.

CFR Gateway works with any PC-based laboratory software or instrument application running on Windows, including standalone instrument software, chromatography data systems, spectroscopy tools, and even standard desktop applications like Microsoft Excel that are used in lab workflows. It operates at the operating system level, so it is not dependent on the instrument make, manufacturer, or software version. Any application that can run on a Windows-based PC can be brought under CFR Gateway's compliance controls — making it a universal solution for mixed instrument environments.

CFR Gateway enforces data integrity through five core controls that align with ALCOA+ principles. First, it requires authenticated user login at system startup before any application can be accessed. Second, it applies role-based access control so only authorised users can open specific applications or view data. Third, every user action including logins, logoffs, data creation, and modifications — is captured in an immutable, timestamped audit trail stored on a secure server. Fourth, all files are subject to version control, preventing accidental or intentional overwriting. Fifth, no data can be stored locally on the user's PC; all records are automatically transferred to the central secure server, maintaining a single source of truth

No, that is the core value proposition of CFR Gateway. Replacing a non-compliant lab instrument or its proprietary software to meet 21 CFR Part 11 requirements can cost tens of thousands of dollars and take months. CFR Gateway eliminates that need entirely by acting as a compliance wrapper over your existing systems. Your instruments continue to operate exactly as they do today, but now within a fully controlled, auditable environment that satisfies FDA and EMA regulatory requirements. This significantly reduces both the cost and the time required to achieve compliance. Book a Live Demo with Our Experts
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