Regulatory expectations for the qualification and control of IT Infrastructure are well established following a series of high profile regulatory inspections. Less well understood are the principles by which risk management can be used to cost effectively qualify and control a Life Science organizations IT Infrastructure. With our own qualified data center, Business & Decision truly understands the importance of pragmatic IT infrastructure qualification and is applying these principles to leading edge technology such as scalable virtualization.

Risk-based IT Infrastructure Qualification

As members of the GAMP® IT Infrastructure Special Interest Group, Business & Decision's consultants have extended the principles of the resulting GAMP® Good Practice Guide (IT Infrastructure Control and Compliance) to develop a unique risk-based approach to the qualification and control of IT Infrastructure.

Using accelerators and templates from their unique Validation Library, Business & Decision's consultants help clients to cost effectively meet regulatory expectations through a combination of risk-based qualification and the use of IT industry best practices, extending the approach to leading edge technologies such as virtual machines, open source software and outsourced infrastructure.

Delivering Business Benefit through IT Infrastructure

As well as meeting regulatory expectations, qualified and controlled infrastructure is less expensive to operate and maintain and delivers sustainable business benefit through greater availability and reliability.

As well as considering hardware and software platforms and components, this approach is also extended to IT process compliance and the validation/qualification of Service Oriented Architectures and Middleware.

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