Part 11 Assessments and Compliance Assessments

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 for compliance.

Part 11 Assessments are 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 perform the 21 CFR Part 11 assessment on 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.

Expand your Market into Pharma

The range of opportunities in the pharmaceutical, biological, clinical, and medical device fields entice many companies to enter these FDA-regulated areas. Even more companies wish to supply FDA-regulated businesses. Gaining satisfactory control over once-informal processes requires significant changes to your corporate culture.

Ofni Systems has guided several companies through the process of creating procedures to manifest 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 with regulated companies. Ofni Systems will work to find the best way for your company to meet 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 FDA-regulated business or want start supplying FDA-regulated businesses, Ofni Systems can assess your systems and identify the best way for your company to meet the requirements of regulated industry. Our experts understand what FDA-regulated companies require from their approved suppliers. We have worked with companies just entering the market, large companies ensuring their continued compliance, and with the regulatory bodies themselves.