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Posted: Mon Jan 28, 2008 8:06 pm Post subject: COBIT vs GAMP
Hello, may I know if there is any analysis report / research between COBIT and GAMP?
For what I understand, cobit is a refrence model for IT auditing and IT governance which defines a quantity of control goals for the computer processes. GAMP is a detailed manual for validating automated systems in the pharmaceutical industry according to the guidelines of the FDA. However, Although the GAMP document has been written specifically with manufacturing systems in mind it is recommended as a general reference as the principles contained within it are general and can be applied to the validation of systems of all types.
I found similar contents for both like change control, risk management, user requirement management, and etc. Can we say that COBIT can indirectly make all the requirements in GAMP being fulfilled? Kindly advice.
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