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1. (WO2018052327) METHOD FOR RISK-MANAGEMENT OVER LIFECYCLE OF COMPLEX PRODUCTS AND PROCESSES

Pub. No.:    WO/2018/052327    International Application No.:    PCT/PT2017/000006
Publication Date: Fri Mar 23 00:59:59 CET 2018 International Filing Date: Sat May 06 01:59:59 CEST 2017
IPC: G06Q 10/06
Applicants: 4TUNE - CONSULTADORIA E SERVIÇOS DE ENGENHARIA INDUSTRIAL, LDA.
Inventors: ROBALO, Tiago
MACHADO, João E.
FELIZARDO, Pedro M.
MENEZES, José C.
Title: METHOD FOR RISK-MANAGEMENT OVER LIFECYCLE OF COMPLEX PRODUCTS AND PROCESSES
Abstract:
A method for building risk-management workflows ('Step A'), comprising severa1 risk analysis tools seamless integrated ('Step B1), 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 workf lows ( 'Step A' 1 with 'Step B' features combined, supports the type of activities in steps 'E1 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' ).