A method for building risk-management workflows (‘Step A’), comprising several risk
analysis tools seamless integrated (‘Step B’), to be applied to
process design, process and equipment qualification, manufacturing stages and
supply management (‘Step C’) of multi-step
processing of chemical, pharmaceutical or
biologic products (‘Step D’), for
risk identification, assessment, mitigation and management over lifecycle (‘Step E’), thus supporting ongoing process verifications, product quality reviews, and knowledge-based process and product continuous improvement (‘Step F’). Workflows (‘Step A’) can be specific of certain stages (‘Step C’), products (‘Step D’), production equipment or facilities used to produce products, but can and should be combined to support the lifecycle management aspects of steps ‘E’ and ‘F’. The use of workflows (‘Step A’) with ‘Step B’ features combined, supports the type of activities in steps ‘E’ and ‘F’, provides a knowledge-management framework (‘Step F’) applicable across multiple products and platform technologies, that supports a science-based justification to decisions taken at defined lifecycle stages (‘Step C’).