| (Continues from previous page)
The validation of more simple, commercially available systems does not warrant such attention to system design and development, but focuses on actual usage. For these, the System Implementation Life Cycle proposed by the 'GAMP Good Practice Guide: Validation of Laboratory Computerized Systems' is much more applicable. With hardware and software so inextricably linked, categorisation is applied at the system level, and validation targets only the actual functionality to be used, which is considered to represent a risk.
Whatever you need, we can help.
CONTACT US to find out how.
|