Compliance Solutions for FDA 21 CFR Part 11

Ofni Systems provides industry-leading software and services to companies who must be compliant with FDA 21 CFR Part 11, Electronic Records; Electronic Signatures. The goal of Part 11 is to protect the electronic data within your systems; our software and services will ensure your company is compliant with all aspects of 21 CFR Part 11. We also offer a full range of training courses on all aspects of FDA regulations, requirements, guidance documents, and validation practices.

FDA 21 CFR Part 11 Information

FDA Part 11 Compliance Consulting and Services

Software Solutions for CFR 21 Part 11

21 CFR Validation Tools and Services