About Ofni Systems

Ofni Systems, a private computer compliance services and software company, is headquartered in Research Triangle Park, NC. Ofni Systems was founded in 1999, dedicated to helping companies address the requirements of 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.

For more than twelve years, Ofni Systems has been a leader in providing regulatory compliance solutions for pharmaceutical, biotech, and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They are also the creators of the FastVal validation software for generating and executing validation documents and have been providing professional validation services using FastVal since 2006. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while their products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures.

Ofni Systems software is designed to integrate with your existing 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.

Ofni Clinical – Compliant Clinical Trial databases, implemented in days, not months

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.

Contact Information

E-mail: info@ofnisystems.com

Phone:(919) 844 2494

Address:
Ofni Systems Inc.
808 Salem Wood Drive, Suite 103
Raleigh, NC 27615-3345