Overview

Assurance Technology Management offers its customers a suite of services that accelerate the process of creating all of the documentation they need to qualify their IT Network Infrastructures under the GAMP 5 guidelines. ATM develops all of the detailed content for their clients specific system, efficiently and at the same high level of quality, they demand of all of their other GxP validated systems. Companies that operate under FDA regulations (and other international oversight agencies) have well established QA processes for validating their critical lab, manufacturing, testing and other GxP systems. Today, FDA and CRO clients are demanding that similar attention be paid to the Network Infrastructure that interconnects these systems, and demonstrate that their Network Infrastructure has been properly qualified in accordance with industry best practices and GAMP 5 guidelines. ATM bridges the gap between QA and IT departments by delivering customized documents in all areas of the qualification process specific to the firm's Network Infrastructure. Our team of experts offers over 60 years of combined expertise in designing, building and managing complex, mission critical networks and support systems in various highly regulated environments, including the Pharmaceutical, Medical Device and Health Care industries. This technical experience, combined with our proven approach to Infrastructure Qualification, offers a cost effective solution to any firm that is looking to bring its entire technical infrastructure into compliance with an oversight agency's strict requirements and to ensure that the firm's IT Network Infrastructure complies with the same level of quality expected of their other GxP systems.