Ofni Systems Inc. services

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

Method validation is the documented process of ensuring a test method or assay is fit for its intended purpose. Regulatory guidelines dictate that analytical test methods used during drug discovery, development, and production will be validated and that validation activities will be summarized in a detailed summary report.

As the FDA increases regulatory enforcement of 21 CFR 11, 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 for compliance.