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.

Assessing your Systems is the first step to Controlling your Systems

Ofni Systems helps companies identify issues with their electronic systems. 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. We will provide you with a full documented risk assessment report for each system, and if necessary, develop a remediation plan that will work within your corporate culture. Ofni Systems can provide your employees with the training to remain in compliance with all applicable regulations.

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

Expand your Market into Pharma

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. Our experts understand what pharma companies need and require from their suppliers. 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.

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.