Ofni Systems, based in Raleigh, NC, specializes in providing FDA-regulated businesses with software and products to ensure compliance with electronic data and signature regulations, including 21 CFR 11, Annex 11, and HIPAA. Their offerings include ExcelSafe for MS Excel spreadsheet compliance, FastVal for validation management, and Ofni Clinical for clinical trial data collection.
With a focus on electronic records compliance, Ofni Systems offers services such as software validation, process automation, and compliance testing, along with consulting services for quality and regulatory needs. Their expertise in 21 CFR Part 11 and Annex 11 aims to simplify knowledge management for organizations seeking to meet regulatory requirements.
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