IT Validation

Life Science industries such as Medical Device, Pharmaceutical, Biotechnology and Diagnostics have requirements set to ensure products manufactured are safe and meet strict quality standards throughout the entire process of production. During implementation of ERP systems, data and processes that are governed by GxP regulations must be identified and documented. Detailed assessment must be performed to address the probability of risk for each GxP functional process and determine a proper risk priority, which in turn, will define the testing strategy. We offer validation services by offering documented evidence which provide high degree of assurance to a desired result with predetermined compliance.