Our Quality Management System meets all industry best practices for Life Science and Healthcare organisations and is incorporated into our day-to-day operational procedures. The scope of this system covers Validation, Risk Assessments, IT Change Management and Regulatory Alignment.
In addition we can provide GxP qualification services to support your infrastructure solutions through our five phase qualification package that is aligned with GAMP5 and ensures compliance against global GxP infrastructure mandates. The qualification package structure covers the Qualification plan, Risk treatment, Infrastructure architecture specification, Infrastructure Qualification and Qualification summary.
Our GxP and Health IT data centre qualification involves first defining key components and identifying the key configuration of each one. We then create a design specification before actually ‘qualifying’ each of the components. Once qualified the components are placed under change management and their compliant state is maintained through their respective life cycles.