Ofni Systems wants to thank all of our clients for 10 years of quality consulting and compliance software. Ofni Systems was founded in 1999, dedicated to helping companies address the opportunities present in 21 CFR Part 11, Electronic Records and Electronic Signatures. Ofni Systems has been fortunate to have the opportunity to work with some of the best companies in the pharmaceutical, medical devices, clinical research fields. 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.

Leaders in Validation and Compliance Services

In ten years, Ofni Systems has become 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 also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.

Ofni Systems products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe and Ofni Systems products for computer validation, auditing and FDA submissions ensure that clients meet every requirement for electronic records and electronic signatures.

Additional Resources

Additional information is available on specific types of validation:

• FastVal Validation Document Generator
• ExcelSafe
• Part 11 Toolkit
• Validating Computer Systems
  • Validating MS Access Databases
  • Validating MS Excel Spreadsheets
  • Validating Web Pages and Web Applications
  • Validating Mi-Co User Forms
• Process and Equipment Validation
• Cleaning Validation
• Compliance Training
• Part 11 Assessments
• Custom GxP Programming
• GxP Auditing