Description based on online resource; title from PDF title page (Safari, viewed Feb. 6, 2013).

Includes bibliographical references and index.

ISA-88 provides a framework for a pharmaceutical process module library -- ISA-88 design and implementation case study for a complex bulk pharmaceutical batch process -- Managing complex equipment status in a GMP environment -- Impact of batch software upgrades on validated batch applications -- Is it possible to build a pharmaceutical plant in 18 months or less using ISA-88? -- Batch on-line analytics : a solution beyond six sigma -- Implementing ISA-88 across life science development operations -- Process definition management : using ISA-88 and BatchML as a basis for process definitions and recipe normalization -- ISA-88 design and implementation case study for a pharmaceutical batch process -- Product life-cycle stages linked using ISA-88 and ISA-95 --

Jazz up your batch projects -- The challenge of integrating multiple batch systems to global business systems -- The road to full MES integration : practical experience from the pharmaceutical industry -- MES roll-out in a regulated environment : reducing the costs of validation based on risk assessment -- Fast and efficient configuration and integration of automation solutions from a global perspective : a practical approach -- Risk-based engineering assessment and qualification : a case study -- Lean computer validation through a risk-based approach : a case study -- Multiple products in a monoclonal antibody ISA-88.01 batch plant -- Considerations for managing global recipe development -- General recipes as contracts with manufacturing -- Using general recipes for standardized multiple plant manufacturing science -- Manufacturing science model extensions to address lean manufacturing and supply chain optimization -- Manufacturing science model extensions to address product and process sustainability -- Manufacturing science model extensions to address quality by design and risk assessments -- Batch release and material use reporting : a case study.