Leaders in Regulatory Compliance Solutions

Ofni Systems is dedicated to helping companies address the requirements in 21 CFR Part 11 Electronic Records and Electronic Signatures and Annex 11, Computerized Systems.

The FDA, pharmaceutical and biological products manufacturers, medical devices and clinical trials organizations use Ofni Systems' software and consulting services to streamline their paper based processes, ensure data security and verify compliance with regulations for use of electronic data.

Ofni Systems software automates complex record generation and provides the technological tools necessary for several common software applications to be compliant; our consulting services ensure that you can maintain your systems in a validated state.

Whether you are a CIO of a global corporation or heading a start-up, Ofni Systems can assess your compliance, validate your computer systems, equipment and processes or assist your company with developing policies and procedures for electronic data control.

Automate Your Company validation process in full compliance with 21 CFR 11.

  • 70% less time required than traditional validation methods.
  • Integrates into your quality systems and validation process.
  • Track and report your validation project status.

Make any spreadsheet compliant with FDA, GxP or EU requirements for electronic

  • Automatic protection for all of your spreadsheets.
  • Simple to Use, select your spreadsheet and use Excel normally.
  • Turn your existing spreadsheets into data collection tools

Rapidly create secure, regulatory compliant clinical trial databases.

  • Automates the creation, review, and resolution of data queries.
  • Includes extensive edit check and data validation features
  • Is compliant with 21 CFR 11, Annex 11, and HIPAA requirements.

Services We Offer