Title 21 CFR Part 11 consulting

Meet software compliance requirements in a regulated environment

Regulatory compliance

Ensuring software meets 21 CFR Part 11 requirements

Technical solutions

Best solutions for identified areas of non-compliance

Seamless integration

Compliance features integrated into existing or new software

21 CFR Part 11 compliance: Expert software development for IVD Medical and GxP applications

Work with our experienced consultants to build a 21 CFR Part 11-ready software for your target market. Our experts have hands-on experience in IVD medical and GxP-ready software development.

We help you analyze your existing software applications, identify areas of non-compliance, and recommend best practices and technical solutions to ensure compliance with the regulation. If you do not have existing software, we can develop a compliant solution from the ground up to meet all regulatory requirements.

Thorough 21 CFR Part 11 consulting services

Our 21 CFR Part 11 consulting services include:

 ✔ Compliance Analysis: Our consultants thoroughly analyze your existing software applications to identify areas of non-compliance with 21 CFR Part 11. This includes reviewing current practices, documentation, and technical setups.

 ✔ Recommendations and Solutions: Based on the compliance analysis, we provide tailored recommendations and technical solutions to address identified gaps. Our experts advise on best practices and necessary changes to ensure full compliance with the regulation.

 ✔ Feature Development and Implementation: Working closely with your development team, we assist in developing and implementing 21 CFR Part 11 features into your software. This ensures that all regulatory requirements are met efficiently and effectively.

 ✔ Documentation Support: We provide comprehensive support for creating and maintaining software-related documentation required for 21 CFR Part 11 compliance.

AdInstruments software

Comprehensive software development services

We support your software development project at every stage, from software documentation to UX design and cybersecurity, along with many other services, helping you bring your product to market faster.