Engineering & ASTM E2500 deployment for a biopharmaceutical group

Compliance & Remediation Life Sciences Belgium

Context and challenges

The client is a European Biopharmaceutical Corporation going through large CAPEX projects.
This group had an internal dedicated engineering team (> 20 field engineers) who faced heterogeneity in engineering documentation and practices. The company needed to enhance knowledge based on engineering good practices.
The project aimed at:

  • Developing a suite of engineering guidelines describing key development phases, which could be immediately used and deployed on project
  • Defining a roadmap to improve engineering best practices over-time

Assystem Care was appointed to support the engineering department in order to improve current engineering standards and set up project management easy-to-use set of tools.

Project scope

  • Set up of a project plan with the customer, focusing on selected key systems
  • Project scoping, identification of targets, project plan, milestones and key deliverables
  • Development of a 10-step roadmap, split in 15 individual engineering modules
  • Use of a specific tool, a smart platform, part of the Apollo solutions (KorteX), comprising the latest engineering guidelines. The documentation and tools integrated the most recent quality and compliance standards

Client benefits

  • Optimal flexibility for engineering project plans, with the ability to use these modules individually or combined with each other
  • Development of visual instructions as part of the packages, in order to ensure smooth and efficient deployment within the teams and to avoid any potential quality and/or engineering issues
  • Improvement of client knowledge in terms of engineering, enabling teams to manage next revisions of documentation

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