Tools and Services for Compliance
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.
Ofni Systems Tools for Compliance
Produce validation documents, manage validation projects and execute testing protocols electronically in 70% less time.
Makes existing MS Excel spreadsheets compliant with all the technical requirements of 21 CFR Part 11.
Clinical trial management software, creating and implementing compliant clinical databases based on your CRFs.
Part 11 Toolkit
Transform MS Access programs into powerful, secure systems that meet all requirements of Part 11.
Part 11 Advisor
Assess all of your computer systems for compliance, perform gap analysis and create corrective action plans.