Moderna

Documentation Management Process Revamp — SOP, DHR, Validation Reports

Redesigned Moderna’s documentation workflows for SOPs, DHRs, and validation reports — eliminating manual inefficiencies and reducing lead time by 70% through digital streamlining.
HOW WE HELPED
  • Led the end-to-end walkthrough of the documentation process, covering SOPs, DHRs, and Validation Reports
  • Mapped current state and identified process inefficiencies and bottlenecks
  • Conducted waste analysis revealing 50% of inefficiencies stemmed from manual processing
  • Facilitated idea generation sessions to develop digital and streamlined workflow solutions
  • Designed a future-state process with a focus on automation and operational efficiency
  • Achieved a 70% reduction in lead time, cutting labor needs by five FTEs
  • Process Lead Time Reduction

    70%

    Manual Inefficiency Share

    50%

    Labor Cost Savings

    5 FTEs reduced

    Docs Covered

    3 types
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