Computers are widely used during development and manufacturing of drugs and medical devices. Proper functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data. Computer Systems Validation (CSV) is all-pervasive in the Life Sciences Industry. Our experienced validation team will document the consistency, quality, and accuracy of your systems, methods, and processes. We understand the different validation requirements for GMP, GLP, and GCP systems and the best ways to ensure compliance with FDA regulations. We have the expertise to follow your validation procedures or assist your organization in cr
Our team is well versed in US FDA 21 CFR Part 11 as well as EU Annexure 11 requirements and can work with your organization to develop a structured methodology for achieving 21 CFR Part 11 Compliance while leveraging a risk based, scientific approach.