 |
Computer software
Tests and documentation must assure confidence in the control system.
Validation of software to be used in the control of a chromatographic system can be divided into a vendor-related part and a user-related part.
The user-related part of software validation is covered by the IQ of the software controlled system, and by the system function verification tests performed during OQ. Both activities are performed at the user site.
The vendor-related part of software validation is a review of design specifications, development, implementation, documentation and testing that has been performed by the vendor. This review is to assure that quality is an integral part of the software and that validation has been considered and built into the software from start. It may include items such as:
- Vendor SOP review
- Test record review
- Documentation review
- Source code review
- System performance and stress testing in normal recommended hardware configurations and environments
- Vendor disaster plan review
This type of information is available from GE Healthcare in form of a Validation Support Package for the UNICORN™ software. The package assure system owners that UNICORN has been developed in a structured manner and tested and documented in accordance with the System Development Life Cycle concept.
|
|
