Experts in 21 CFR 11 & Annex 11 Compliance Software Custom programs for FDA regulated businesses
Need Validation Help?
While there are a number of excellent, compliant programs available on the market, sometimes you need software designed to meet your exact needs. Ofni Systems can create an easy to use, custom computer system to meet your exact requirements and provide the training and support you require to ensure successful implementation.
Experts in Creating Compliance Computer Systems
Ofni Systems can assist with all phases of a computer development project:
- Gathering Requirements: If you need assistance gathering requirements, our professionals can travel to your site, talk with managers and key end-users, and help you to reach consensus about program business requirements.
- System Development: Ofni Systems will design a custom program, database, or web-based application to meet your exact needs. Our staff of developers are experts in balancing compliance with friendly user interfaces.
- Testing and Validation: Ofni Systems can validate your custom programs to ensure compliance with 21 CFR 11.10(a). We can help you with all aspects of testing, including creating, reviewing, and executing test protocols.
- Implementation: Ofni Systems can create training materials, help files, and classes to teach your employees to use the new system, migrate existing data into your new system, and maintain the system as long as you require.
How can Ofni Systems help you?
Guaranteed Compliance with 21 CFR 11
Ofni Systems programs are technologically compliant with 21 CFR Part 11; all of our programs include standard features like user-level security, audit trails, event logging, and program time-outs.