In parallel with our contribution to the GAMP IT Infrastructure Control and Compliance Good Practice Guide, Business & Decision developed a comprehensive Quality Management System specifcally designed to meet the needs of our Life Sciences clients.

Leveraging IT industry best practices such as ITIL (ISO 20000) and security standards such as ISO 27000, hosting and managed services are provided under a risk-based approach to IS compliance. Maintained under a controlled series of Policies, Proedures and Work Instructions, all infrastructure is appropriately qualified and all staff receive regular GxP awareness training.

This provides a compliant and cost effective baseline for maintaining the validated state of client's validated applications.

Audit and Inspection Ready

Our Quality Management, Technical and IS Compliance staff are ready to host not only the regular audits of our clients, but also regulatory inspections by international regulatory agencies. Although a well maintained and validated application is unlikely to lead to a data center inspection, the fact that our consultants have supported clients during multiple on-site inspections by agencies such as the US FDA and UK MHRA provides assurance that we are ready to host any audit or inspection.

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