General Principles of Software Validation

  • By: Staff Editor
  • Date: December 05, 2016
  • Source:
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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.


This rule applies to:

  • Software used as a part, or accessory of a medical device
  • Software that is itself a medical device e.g., blood establishment software
  • Software used in the manufacture of a device e.g., programmable logic controllers in manufacturing equipment
  • Software used in application of the device manufacturer's quality system e.g., software that records and maintains the device history record.

Software Validation Requirements

Software validation is a requirement of the Quality System Regulation (QSR), which became effective on June 1, 1997. The FDA dictates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all devices should be validated. Since then, regardless of the device class, unless specifically exempted all device software products are subjected to applicable design control provisions (21 CFR §820.30.).

Additionally, validation requirements also applies to computes system used to generate, change and maintain electronic records and electronic signatures.

Related Training:

The 6 Most Common Problems in FDA Software Validation & Verification

Software Validation: Avoiding FDA Warning Letters and Consent Decree

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