$154
AAMI TIR36:2007
2007
Validation of software for regulated processes
- Format:
- Language(s) :
- Published :
- English
- 12/13/2007
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 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.
| AAMI TIR36:2007 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI TIR36:2007 |
| Scope | Validation of software for regulated processes |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation |
| Languages | English |
| State | [ Withdrawn ] |
| Publication Year | 2007 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 1.8 MB |
| Note | This product is unavailable in Belarus, Russia, Ukraine |
| Number of Pages | 111 |
| Published | 12/13/2007 |
| AAMI TIR36:2007 | ||
|---|---|---|
| History | Publisher Year | |
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