About Us | Eleven Tech

Our Background

Eleven Tech was founded by engineers with deep experience in scientific instrumentation software, particularly in the spectroscopy domain. Our team has spent years designing and implementing control software for analytical instruments used in pharmaceutical, biotechnology, and life science laboratories.

Through this work, we've developed comprehensive expertise in FDA 21 CFR Part 11 compliance - the regulations governing electronic records and electronic signatures in FDA-regulated industries. We understand the technical requirements intimately because we've implemented them in production systems.

We recognized that many software teams struggle with CFR Part 11 compliance - not because they lack programming skills, but because they lack domain expertise in regulatory requirements. That's why we created our SDK and consultation services: to help teams achieve compliance efficiently without reinventing the wheel.

Our Expertise

Specialized knowledge developed through years of hands-on experience.

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Spectroscopy Instruments

Deep experience with fluorescence spectrometers, UV-Vis systems, Raman spectrometers, and other analytical instruments. We understand the unique requirements of instrument control software.

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Instrument Control Software

Years of designing and implementing real-time instrument control, data acquisition, and analysis software. From low-level device communication to high-level user interfaces.

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CFR Part 11 Compliance

Practical implementation experience with electronic records, electronic signatures, audit trails, access controls, and data integrity requirements mandated by FDA regulations.

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.NET Development

Strong expertise in C#, .NET Framework, .NET Core, WPF, and modern software architecture patterns. Our SDK is built on .NET Standard 2.0 for maximum compatibility.

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Database Design

Experience with SQLite, PostgreSQL, SQL Server, and Entity Framework Core. Provider-agnostic design that works with your existing database infrastructure.

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Security Implementation

Cryptographic best practices including secure password hashing, tamper detection, and proper key management for regulated environments.

Our Approach

Engineering-first solutions for regulatory compliance.

Understand Your Requirements

We start by understanding your specific application, regulatory requirements, and existing architecture. Every project is different.

Practical Solutions

We provide practical, implementable solutions - not theoretical frameworks. Our SDK and guidance come from real-world implementations.

Technical Depth

We speak your language. Expect detailed technical discussions about architecture, database design, and security implementation.

Ongoing Support

Compliance isn't a one-time task. We provide ongoing support to help you maintain compliance as your software evolves.

About Eleven Tech