Validating a computer system

The organisation had verbally described a robust testing process involving white box testing by the developers to test the application at the level of the source code and black box testing to examine the final functionality of the application by independent developers acting as end users who were not involved in the project and had no knowledge of the development using formalised test scripts.Evidence of this testing was therefore expected in terms of formally approved and completed test scripts populated with the outcomes of the testing.

Following the failure there was no documented evidence to demonstrate the issue had been rectified.The guide is especially useful for users of computer systems.FDA Training Manual for Inspectors FDA Investigational Training Manual This chapter 22C of the FDA investigational training manual has been developed for FDA inspectors as a guidance on how to inspect computer systems.The manual has been developed in the 90's and looks rather old but the basics are very much up-to-date and strongly recommended to be followed in preparation for FDA audits.FDA Guidance for Industry and Reviewers Off-The-Shelf Software Use in Medical Devices This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a pre-market submission to the FDA when they use off-the-shelf software (OTS).

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