Validation of software for regulated processes
Summary: Applies to any software used to automate device design, testing, component acceptance,
manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other
aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). In
addition, it applies to software used to create, modify, and maintain electronic records and to
manage electronic signatures that are subject to the validation requirements (21 CFR 11). This
TIR can also be broadly applied wherever software automates processes regulated by the FDA.
This TIR applies to software used in the production of a device and to software used in
implementation of the device manufacturer’s quality system. It does not apply to software used as
a component, part, or accessory of a medical device or software that is itself a medical device.
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