Framing of the digital PLM project of a European pharmaceutical leader | Mews Partners
01

Problematic

The main challenges of the program are to reduce product development time & cost, improve industrial agility and competitiveness, and also to strengthen quality, compliance, regulatory compliance and intellectual property control. In addition to these challenges, an important challenge is to define what PLM means for the pharmaceutical and biotechnology industries and what role it plays in terms of digital continuity.

02

“The extent to which design, production and associated context data are reconciled is the key challenge of the pharmaceutical industries.”

Process

In order to capture the main elements of the context and expectations, interviews related to  both synthetic and biological products were conducted. A training course was organized to increase the skills of the teams and make them understand the challenges of the PLM. Workshops were then launched to carry out a diagnosis of the complete development process (development, transfer, launch), define the conceptual data model, functional mapping and mapping of target business processes with regard to the management of structural data. Prioritization was carried out in order to propose a vision of PLM that reconciles design and manufacturing data and ensures digital continuity throughout the lifecycle.

4

months of diagnosis

60

people involved

Result

03

Result

10 major issues were identified as well as the associated cultural issues: collaboration foundation, product & process data validation, capitalization & reuse, manufacturing process management, data configuration management, organization & business process, partners, regulatory, data management tools, big data.

A mapping of the impacted processes, a synthetic and bio data model as well as a process mapping were produced. These elements made it possible to develop a project roadmap and a business case focused on the digitalization of laboratories.

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