Recognizing a critical need in the pharmaceutical and biotech industry to supply expertise in the area of FDA compliance, CSI was formed in 2004. CSI’s strength lies in its 60 years combined experience integrating computer science with pharmaceutical science. CSI’s principal consultants are committed to using their knowledge base to ensure project quality and customer satisfaction.
Pharmaceutical, biotechnology and medical device industries must meet increased government regulation in the global market place. Success in the drug and medical device industries depends on accelerating the development and clinical testing process while meeting the quality standards for licensure and registration. Automated computer systems are essential to realizing this acceleration and must comply with (U.S. 21 CFR Part 11) regulations as well as validation standards. By utilizing the expertise at COMPLIANT SYSTEMS INTEGRATION, INC., companies can raise the performance bar, improve new product cycle times and achieve quality compliance necessary for successful licensure.