We are Scotland’s first Life Sciences and Healthcare compliant datacentre, specifically aligned to GxP, FDA, 21 CFR Part 11, EU Annex 11, MHRA and NHS regulations.
With our unique hosting service you will receive all the benefits of the datacentre along with a qualified and validated solution that has been specifically designed to meet the regulated needs of these industries.
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.
To achieve and maintain GxP / 21 CFR Part 11 or Annex 11 compliant IT Infrastructure we are under revision control, approved and trained on all of our processes.
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.
For co-located hardware or dedicated managed hosting this typically takes the form of a traditional Installation Qualification (IQ), with the additional steps verifying both the existence of the data centre’s QMS and their qualified infrastructure.
Validated co-location services
As a result, organisations that require hosting for regulated data, compliance critical application hosting or a fully qualified platform for validated systems can utilise our validated co-location services that are secure and always ready for audit.
Our compliance checklist provides a trace between the documents and alignment to the relevant regulatory requirements that apply.