IT Infrastructure Qualification

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Business & Decision Life Sciences’ consultants are leaders in the field of IT infrastructure qualification in the Life Sciences industry and continue to develop risk-based industry best practices.

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 organization's IT infrastructure. With its own qualified data center, Business & Decision Life Sciences 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 Life Sciences’ 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 Life Sciences’ 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 Benefits through IT Infrastructure

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

While 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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