What AI says about Part 11 Advisor

Ofni Systems provides software and consulting services to help FDA-regulated organizations achieve regulatory compliance for electronic records and signatures under 21 CFR Part 11, Annex 11, and HIPAA. Their products include ExcelSafe for Part 11 compliance of MS Excel spreadsheets (with audit trails, electronic signatures, user security, and validation), FastVal for validation management, Part 11 Advisor for auditing/remediation/training, and tools like the Part 11 Toolkit and Ofni Clinical eCRF for data collection in clinical trials. They offer on-site implementation, training, and a range of validation and compliance services (validation, process automation, mock audits, SOP writing) to support regulatory readiness.