AAMI TIR36 2007

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 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.