Ofni Systems, a private computer services and software company, is headquartered in Research Triangle Park, NC. Ofni Systems was founded in 1999, dedicated to helping companies address the opportunities present in 21 CFR Part 11, Electronic Records and Electronic Signatures. This regulation gives companies the freedom to do away with paper-based systems and streamline nearly every part of their operations. FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials, utilize Ofni Systems’ proven software and consulting to become compliant with 21 CFR Part 11 and add value to their business processes.

Ofni Systems has tools which allow MS Excel and MS Access to be made technologically compliant with 21 CFR Part 11, HIPAA and Annex 11. Our quality professionals use our proprietary software to automate complex record generation, allowing us to produce the highest quality materials, quickly and efficiently. Ofni Systems software is designed to integrate with your existing spreadsheets, systems, SOPs and policies for electronic data, complementing your existing workflow. If your company needs assistance with assessing compliance, computer validation or developing policies and procedures for electronic data control, let Ofni Systems make knowledge management simple for you.

Ofni Systems Products & Services


FastVal - Generate Validation documents and manage validation projects.

ExcelSafe - 21 CFR 11 compliance for MS Excel

Part 11 Toolkit - 21 CFR 11 compliance for MS Access

Part 11 Advisor - Implement and manage compliance remediation plans

GxP Auditor - Manage and Track Compliance Audits

MedWatch Reporter - Create and track FDA form 3500A

Part 11 Assessments - Determining your compliance status.

Computer Validation - Test and document your computer compliance status.

Custom Programs - Create compliant programs to meet your needs.

Compliance Training - Train your employees

Compliance Auditing - Review your compliance in an open, honest manner.

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