Many companies in the Life Sciences and Pharmaceuticals Industry are feeling the crushing burden of operating in a highly regulated environment. In addition to SOX compliance required for public companies, they have to deal with FDA compliance, DEA rules, not to mention process-related controls and access controls related to ERP applications, legacy applications and IT security tools. Change control processes as well as designated role assignments mandated by FDA 21 CFR Part 11 and various sub parts require establishing controls and compliance procedures to avoid heavy fines and criminal penalties.
A more comprehensive view of risk involves a combination of IT risk, risk of access to facilities and assets and risk of change to lab and production processes. AlertEnterprise delivers a single unifying solution that extends across IT applications like ERP, GRC and IAM as well as physical security applications and production processes, delivering true security and business alignment by hiding the complexities of integration.