An IT audit is critical to achieving a stable and efficient IT infrastructure that meets your business and regulatory compliance requirements. A holistic approach should be taken which considers all aspects of your systems and controls.
By conducting an IT audit we aim to capture not only the technical details of your various IT systems, but also the corresponding IT processes and their interactions. These are always tightly integrated, so any deficiencies can have a profound and detrimental affect across all business units. If required, your IT infrastructure can also be reviewed from a regulatory compliance perspective, to validate the design and operating effectiveness of your business-critical applications. This is achieved by identifying and reviewing the IT control environment, access to systems/data, change management and other critical factors. An action plan is then created to resolve any identified issues and control gaps, thus making your system compliance-ready!
Whether we conduct a general IT audit or an IT systems compliance assessment, the end result is a comprehensive written report detailing deficiencies and offering tangible solutions. It forms your strategic IT action plan and a road-map for the future. Find out more or book an audit by enquiring below.
We offer a complete gamut of IT services specialising in the biotech/pharma/health sector, encompassing on-premise, cloud and hybrid systems.
Unlike most other IT service providers, we don't work off a menu of service offerings. Our approach is always holistic and our solutions are bespoke. Our more popular services include: CTO as a service, project management, managed services, helpdesk, security, vendor management, IT governance, risk and compliance and cloud solutions.
Mesoblast is an innovative biotechnology company with an emphasis on regenerative medicine. They requested that Exigence commission an electronic regulatory submission system that supports publications of submissions to the FDA and other regulatory bodies in line with ICH, 21 CFR Part 11 and other international guidelines. In close consultation with the software vendor, Exigence designed and implemented a fully compliant and highly available infrastructure to support the system. The infrastructure was qualified and validated in line with FDA requirements and serves as a core platform for the regulatory submission system.view case study