GAMP 5 and PRODUCT QUALITY LIFECYCLE IMPLEMENTATION (PQLI)

GAMP 5 points to the future of computer systems compliance by centering on principles behind major industry developments such as the Product Quality Lifecycle Implementation (PQLI) or ICH Q9 and Q10.

Find below two articles from the PQLI innovations group regarding computer system design and validation. These articles refer to the ICH guidelines and to the ANSI/ISA S95 and S88 standards, which are used for ERP and Batch Control Systems.

► PQLI Engineering Controls and Automation Strategy

► PQLI Control Strategy Model and Concepts