Services | Eleven Tech

CFR Compliance SDK

A ready-to-integrate .NET library for CFR Part 11 compliance

Our SDK provides a complete, battle-tested implementation of CFR Part 11 technical controls. Built on .NET Standard 2.0, it integrates with both .NET Framework and .NET Core applications.

Core Features

User Management

Complete user lifecycle management
Role-based access control (RBAC)
Granular permission system
User profile with electronic signature support

Authentication

Industry-standard secure password hashing
Configurable password policies
Account lockout after failed attempts
Password expiration enforcement

Audit Logging

Immutable audit trail
Who, what, when, why tracking
Old/new value capture for changes
Cryptographic tamper detection

Data Integrity

Cryptographic data verification
Database integrity checks
Tamper detection on critical entities
Automated integrity verification

Technical Specifications

Database Support: Provider-agnostic (SQLite, PostgreSQL, SQL Server, etc.)
Security: Industry-standard cryptographic security and data protection
Documentation: Comprehensive API documentation and integration guide

What's Included

SDK library for integration into your applications
Sample WPF application demonstrating all features
Comprehensive documentation
Database schema and seed data helpers
Email support for integration questions

Expert Consultation

Personalized guidance for your CFR Part 11 compliance journey

Sometimes you need more than a library - you need expert guidance tailored to your specific situation. Our consultation services provide hands-on help from engineers who have implemented CFR Part 11 compliance in production systems.

Consultation Services

Gap Analysis

We review your existing software against CFR Part 11 requirements and provide a detailed report of what's missing, what needs improvement, and recommended remediation steps.

Architecture Review

Planning a new application? We'll review your proposed architecture and provide recommendations for building compliance in from the start - much easier than retrofitting later.

Code Review

Detailed review of your authentication, audit logging, access control, and data integrity implementations. We provide specific, actionable feedback on your code.

Implementation Guidance

Hands-on help implementing compliance features. We can work with your development team via phone, video call, or screen sharing to solve specific technical challenges.

Validation Support

Assistance with software validation documentation including IQ/OQ/PQ protocols, traceability matrices, and test documentation for CFR Part 11 features.

Training Sessions

Technical training for your development team on CFR Part 11 requirements, implementation best practices, and common pitfalls to avoid.

How It Works

Initial Discussion

We start with a free introductory call to understand your project, requirements, and challenges.

Scope Definition

We define the scope of engagement and provide a clear proposal outlining deliverables and timeline.

Engagement

We work with your team via your preferred communication method - phone, video, email, or screen sharing.

Deliverables

You receive detailed documentation, recommendations, and any code samples or examples discussed.

Industries We Serve

Our expertise is particularly relevant for these regulated industries.

Pharmaceutical

Drug development, manufacturing, and quality control systems requiring CFR Part 11 compliance.

Biotechnology

Laboratory information systems, bioprocessing controls, and research data management.

Medical Devices

Device manufacturing records, quality management systems, and design controls.

Analytical Instruments

Spectroscopy, chromatography, and other analytical instrument control software.

Contract Labs

Testing laboratories serving pharmaceutical and biotech clients with compliance requirements.

Life Sciences

Research institutions and companies working in FDA-regulated research environments.

Our Services