Warning Letter: Failure to validate computer software (g3667d)
Tags: Computer System • Failure to Validate Software • Medical Device Manufacturer
Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820-70(i). For example:
- [redacted]software validation has not been completed.
- [redacted] software validation plan does not address the user requirements of inputting data into the [redacted] spreadsheet used as a tool for trending.
- [redacted] software used for trending has not been validated for its intended uses.
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