We help life science and pharmaceutical companies build software that meets FDA electronic records and electronic signatures requirements. From ready-to-use SDK to expert consultation.
Understanding the FDA's requirements for electronic records and electronic signatures in regulated industries.
FDA's 21 CFR Part 11 establishes criteria for electronic records to be considered trustworthy, reliable, and equivalent to paper records. This includes requirements for data integrity, audit trails, and system validation.
The regulation defines requirements for electronic signatures to be legally binding and equivalent to handwritten signatures. This includes unique user identification, signature manifestation, and non-repudiation controls.
Systems must implement proper access controls including user authentication, role-based permissions, account lockout policies, and session management to prevent unauthorized access.
Complete, immutable audit trails must record who did what, when, and why. Changes to electronic records must be documented without obscuring previously recorded information.
Systems must ensure data cannot be altered, deleted, or corrupted without detection. This includes cryptographic controls, validation checks, and tamper-evident mechanisms.
Software systems must be validated to ensure accuracy, reliability, and consistent intended performance. Documentation must demonstrate fitness for intended use.
Two paths to CFR Part 11 compliant software: our proven SDK or personalized expert consultation.
Ready-to-integrate software library
Personalized guidance for your project
Deep domain expertise combined with practical engineering experience.
Years of experience in spectroscopy instrument control software and regulated environments.
Battle-tested code and methodologies developed from real-world implementations.
Reduce development time with our proven SDK and expert guidance.
Technical depth you need for implementation, not legal jargon.
Our solutions are designed specifically for the unique challenges of regulated laboratory software. From instrument control to data integrity, we understand the intersection of technology and compliance.
Whether you're developing software for analytical instruments, laboratory information systems, or quality control applications, we have the expertise to help you meet CFR Part 11 requirements.
View Our ServicesWhether you need a complete SDK solution or expert guidance for your existing project, we're here to help.
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