“That’s the point,” Elara said. “GAMP isn’t about rigid rules. It’s about building quality into the process from the ground up. The system knows its own limits. It knows when to adapt and when to scream for help.”
She smiled. “Good work, Sigma. Validate and lock.” good automated manufacturing practice
“The deviation is within the dynamic control band. No impact on critical quality attributes. However, I have scheduled an automatic changeover at 06:00, diverting buffer flow through the secondary skid. Maintenance drone 7 will replace the diaphragm during the next sterile hold.” “That’s the point,” Elara said