Challenges
GAMP for computer validation requires quality be built and tested into the process system from the start
Minimize cost by standardizing documentation and technology
Scope
PI System + APERIO + Delta-V Interfaces + Batch Reporting
Benefits
Eliminated unexplained batch deviations which previously caused the loss of an entire batch
Reduced start-up time and CIP cycle time
Easy troubleshooting of start-up issues
Monitored utilities and reduced water usage