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Computer Systems Assurance: A Move Towards Risk-based Thinking

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jack
Computer Systems Assurance: A Move Towards Risk-based Thinking

The FDA’s new Computer Software Assurance takes cognizance of these changing times and the challenges businesses are facing due to the very demanding CSV requirements.

 

The General Principles of Software Validation; Final Guidance (CSV), introduced in 2002 by FDA, is aimed at the validation of the software for medical device quality system and includes all aspects of the software development lifecycle, right from planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering. While recommending the integration of the software life cycle management with risk management, it puts the onus of the quality of the software on the device manufacturer even when it is not developed by them.

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