CSV Program Implementation using a Risk Based Approach to align ICH with GAMP5
Zusammenfassung
it has been 29 years when Process
Validation was created. Since then there has been a
lot of creations of different types of validations.
During the years there have been a lot of
improvements in every validation process. Different
kind of process has been created to support
validations. Quality is an important factor in any
process nowadays. In this project we want to align
a Quality Risk Management process like ICH Q9
with GAMP5 Computerized Systems Validation
process. A DMAIC problem solving method was
used to identify gaps between processes and
provide a clear view to resolve the problems.in
conclusion the best way to align these processes is
to begin with a full risk assessment, risk control
and continue with the GAMP5 process.
Key Terms - Computer Systems Validation,
GAMP5, ICH Q9, Quality Risk Management, Risk
Assessment.