General Principles of Software Validation

• By: Staff Editor
• Date: December 05, 2016
• Source: http://www.fda.gov/

General Principles of Software Validation

Software validation is a vital tool used to assure the quality of software and software automated operations for medical devices. Software validation can increase the reliability and accuracy of the device, subsequently leading to fewer recalls and corrective actions, less risk to patients, decreased failure rates, and reduced liability to device manufacturers.

The FDA guidance details the general validation principles that are appropriate to the validation of device software or the validation of software used to design, develop, or manufacture medical devices.

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