Step 1: Design qualification (DQ)
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Design qualification is the first and most important step of any qualification process. When done right, this can save a lot of time for later qualification phases.
For instruments this means:
1. Documentation of user requirements and instrument functional and operational specifications
2. Qualifying the vendor for appropriate software development and support processes
Agilent Technologies helps you with:
- An extensive list of functional specifications for computer systems. Select appropriate functions and specifications to develop DQ’s for your own intended use. Click here for a complete list of available specifications.
- Documented evidence that software and computer systems have been validated during development according to standardized procedures
- Comprehensive hardware specifications that can be found on Agilent's product web pages for GC, LC, CE, UV-Vis.
It is the users’responsibility to validate the software they use, but without access to the underlying programming routines, software validation is a difficult task. Agilent Technologies validates each product before it leaves the factory and provides documented and certified evidence of sucessful software validation through:
- Compliance with industry standards such as GAMP
- More than 100 successful audits by international pharmaceutical companies
- Declaration of system validation shipped with each product
- Documented development and validation process available on CD through non-disclosure agreement
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