Validation of software for regulated processes

Published by Publication Date Number of Pages
AAMI 12/13/2007 111
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AAMI TIR36 – Validation of software for regulated processes

Applies to any software used to automate device design, testing, component acceptance,manufacturing, labeling, packaging, distribution, and complaint handling or to automate any otheraspect of the quality system as defined by the Quality System Regulation (21 CFR 820). Inaddition, it applies to software used to create, modify, and maintain electronic records and tomanage electronic signatures that are subject to the validation requirements (21 CFR 11). ThisTIR 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 inimplementation of the device manufacturer’s quality system. It does not apply to software used asa component, part, or accessory of a medical device or software that is itself a medical device.

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