TY - JOUR AU - Tyler, Stephen AB - This paper discusses the development of engineering controls and automation strategy required to practically implement a Control Strategy within a Quality by Design environment. It describes the relationship to the ISPE PQLI Control Strategy model, and covers operating philosophy, record keeping, data management, and alarm strategy. Engineering and automation controls may include measurement technologies for equipment parameters (off-line, at-line, in-line or on-line), univariate or multivariate process models and control models, engineering or plant procedural controls and automation systems. Concepts from ANSI/ISA S95 standards are applied. TI - PQLI Engineering Controls and Automation Strategy JF - Journal of Pharmaceutical Innovation DO - 10.1007/s12247-008-9031-5 DA - 2008-05-18 UR - https://www.deepdyve.com/lp/springer-journals/pqli-engineering-controls-and-automation-strategy-dTMjaISV0x SP - 88 EP - 94 VL - 3 IS - 2 DP - DeepDyve ER -