General Principles of Software Validation (FDA guidance)

Context and history

FDA's General Principles of Software Validation is the long-standing reference for software validation in the device world. Version 2.0 was issued on 11 January 2002, replacing a 1997 draft. It describes validation as establishing by objective evidence that software meets user needs and intended uses, and it explains why software needs a life cycle approach.

Its ideas spread well beyond devices, and it remains the foundation that Computer Software Assurance builds on.

Who and what it applies to

Medical device software, and software used to design, develop or make medical devices, including quality system software. It addresses device manufacturers and FDA staff.

What it contains

Section 1 Purpose

Outlines the general validation principles FDA considers applicable.

Section 2 Scope

Applicability, audience, the least burdensome approach, regulatory requirements and quality system regulation versus pre-market submissions.

Section 3 Context

Definitions, how software differs from hardware, and the benefits of validation.

Section 4 Principles

Requirements, defect prevention, time and effort, software life cycle, plans, procedures, software validation after a change, validation coverage, independence, flexibility and responsibility.

Section 5 Activities and tasks

Life cycle tasks through planning, requirements, design, construction, testing, installation, maintenance and changes.

Section 6 Automated process equipment and quality system software

Validating software used in production and quality systems, including off-the-shelf software.

Key points

• Validation requires objective evidence that software meets user needs and intended use.
• Software failures are usually design errors, so a life cycle approach matters.
• Changes need validation appropriate to their risk.
• Validation effort should match risk.
• Independence in review is valued.
• Users of off-the-shelf software remain responsible for validating it for their use.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• Read this with CSA, since CSA changes emphasis rather than its principles.
• Keep requirements traceable, which supports both approaches.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.