For years, Ofni Systems has been helping companies identify issues with electronic systems and provided a full documented risk assessment report for each system. One of the most difficult things for many companies is to know what their computer systems require to be in compliance. Ofni Systems can quickly assess all of your software, databases and computer systems and identify what issues need to be addressed to be in compliance.

Ofni Systems can come directly to your site. Our assessment professionals will take the time to learn your policies and review your software and procedures. If necessary, Ofni Systems will develop a remediation plan that will work within your corporate culture. Not only can Ofni Systems help with your software, policies and procedures, we can provide your employees with the training to remain in compliance with all applicable regulations.

Many pharmaceutical, medical device and clinical research companies rely on Ofni Systems to identify gaps in their policies and procedures. Commercial software providers have relied on our expertise to help them identify gaps in their software products and to help them plan new releases. If you are moving into regulated business, Ofni Systems can assess your systems and identify the best way for your company to meet the requirements of regulated industries.

Benefits of Using Ofni Systems


Ofni Systems can quickly and efficiently assess all of your computer systems and identify compliance gaps. Our validation specialists use our proprietary software, the Part 11 Advisor TM. This allows our specialists to quickly assess your computer systems and produce plans to meet your compliance gaps.

Can Ofni Systems help us with our compliance gaps?


If you have identified compliance gaps or Ofni Systems assessment identifies compliance issues, we can help you address these gaps. Ofni Systems can develop remediation plans, policies and procedures to allow your company to continue to grow while remaining in compliance with all applicable regulations.

We are trying to supply regulated companies. How can Ofni Systems help us?


Ofni Systems can review your systems and train your personnel to work for regulated companies. Ofni Systems will work to find the best way for your company to meet all regulations applicable to your situation.