| Publisher | Bruker AXS | ||
|---|---|---|---|
| Format | 194.6KB PDF | Date added | 30 Nov 2004 |
| Topics | Biometrics | ||
| Downloads | 111 | ||
The purpose of this white paper is to show how the DIFFRACplus BASIC software helps to meet the requirements of the FDA's 21 CFR Part 11 regulation. DIFFRACplus BASIC is being developed by applying a formal design process and product development life cycle according to Bruker AXS's ISO9001 certified product development procedures. Written standards exist such as coding standards, configuration management, programmer qualifications, software version control, maintenance, formal testing of software/hardware, incident reporting and tracking, and disaster recovery.
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