As the FDA increases regulatory enforcement of 21 CFR 11, one of the most difficult things for many companies is to know what technological and procedural controls their computer systems require in order 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 compliance professionals use Part 11 Advisor to quickly assess your computer systems and produce plans to meet your compliance gaps.

The range of opportunities present in the pharmaceutical, biological, clinical and medical device fields make many companies desire entering these FDA-regulated areas. Even more companies wish to supply these FDA-regulated businesses. The control required over processes which were often fairly informal require significant changes to the corporate culture. Ofni Systems has guided several companies through the process of creating the required procedures necessary to demonstrate control over their processes, training employees on these processes and demonstrating that these processes have been maintained.

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.

If you are moving into FDA-regulated business, or want to begin to supply to FDA-regulated businesses, 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 FDA-regulated companies need and require from their approved suppliers. We have worked with companies entering the market, large companies ensuring their continued compliance and with the regulatory bodies themselves.