Design qualification is the documented verification that the proposed design of the equipment or systems to be qualified is suitable for the intended purpose.
2
DESIGN QUALIFICATION PROCESS
2.1
Description of the intended purpose and analysis
2.2
Selection of the analysis technique
2.3
Selection of equipment and suppliers
The following equipment and suppliers have been preliminary selected:
2.3.1 Equipment 1 Equipment 1 is composed of the following instruments: Instrument 1 name: Manufacturer/Brand: Technical specifications: Health & safety requirements: • • • •
• • • •
Instrument 2 name: Manufacturer/Brand: Technical specifications: Health & safety requirements:
Equipment 1 is controlled by the following software: Name and version: Manufacturer/Brand: Technical specifications: • • •
