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What software does the FDA require you to validate?

Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i).

This includes software used to automate:

• device design,
• testing,
• component acceptance,
• manufacturing,
• labeling,
• packaging,
• distribution,
• complaint handling,
• or to automate any other aspect of the quality system.

 Under 21 CFR §11.10(a).Computer systems used to:

• create, modify, and maintain electronic records
• manage electronic signatures

are also subject to software validation requirements to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.