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2022 ISPE Europe Annual Conference

EU22CEAPR1/SES402 - Risk Based Trace Matrix for Agile C&Q Management

Apr 26, 2022 4:30pm ‐ Apr 26, 2022 5:10pm


Agile project management and GMP compliant implementation of commissioning and qualification activities (C&Q) appear to be incompatible. While in a SCRUM process the requirements are continuously developed in close cooperation between cross-functional teams, in a traditional engineering approach, the URS is the first document to be developed, released and thus “frozen”. In SCRUM the implementation and testing takes place in iterative sprints - the sequence for C&Q described in GMP guidelines looks more like a linear waterfall model. Integrated Commissioning and Qualification (iC&Q) is an approach to achieve lean processes and save time, as commissioning can be fully and agilely integrated into qualification activities. By using an risk based and automated traceability-matrix over the project life cycle, changes concerning user requirements as well as C&Q testing can be handled in a more agile way – without losing GMP compliance. In this presentation, the possibilities and advantages of an risk based and automated traceability-matrix is shown with examples out of several EPCM projects. • iC&Q – speed up your engineering projects • Traceability-matrix right from the beginning – the basis for a agile iC&Q strategy • How to set up a risk-based life cycle traceability-matrix • Paperless iC&Q via automated traceability-matrix


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