Improvement plan for regulatory compliance of a vaccines production site

Compliance / Security Life Sciences Belgium

Context and challenges

This client is a major pharmaceutical company, with several vaccines production sites in Belgium.

After an FDA inspection, the company’s representatives committed to reduce to less than 5% the amount of late deviations on a global scale (i.e., greater than 30 days old). This backlog of deviations that had to be corrected affected one of its biological product filling facilities.

Addressing this deviation’s issue was an obligation to ensure compliance with regulation.

Also, the numerous deviations increased internal costs (of investigation, storage, and machine shutdowns) and prevented product release. Indeed, it decreased available stock of products, jeopardizing the supply chain, and thus potential revenues.

This client has appointed Assystem Care to define and set up an improvement plan to reduce the number of deviations in a timely manner to comply with regulatory requirements and implement continuous operational quality improvement measures.

Project scope

  • Phase 1: Reduction of a defined number of late deviations, 5.5 months
    • Kick-off meeting with the client to scope out the project and agree on objectives, project planning, timing, reporting, and key deliverables
    • Organisation of daily meetings and steering committees to provide a project overview and identify blocking points
    • Diagnostic to assess the backlog of deviations
    • Correction of 243 late deviations and implementation of 491 tasks CAPAs (Corrective Actions Preventive Actions)
  • Phase 2: Reduction of backlog and continuous quality improvement
    • Correction of additional 130 deviations and implementation of CAPAs in parallel to prevent future deviations
    • Set up of a charter about standard content required for a deviation and best practices of managing deviations, in collaboration with the client quality assurance team
    • Set up of project management and teamwork tools:
      • Organisation of short meetings on deviations, causes and CAPAs
      • Committee for approval of CAPA implementation
      • Implementation of Cardex, a visual information tool for time and deviations management (daily activities and personal roles)
    • Training of client teams about Assystem Care project management methodologies and tools

Client benefits

  • Time savings in particular on phase 1: deviation and CAPA backlog decreased to zero two weeks earlier than planned
  • Decrease in deviations thanks to project management methodologies and tools (ie Cardex tool, etc.)
  • Compliance to regulatory requirements in a timely and cost-effective manner
  • Efficient management of deviations thanks to spreading best practices tools and methodologies to other departments
  • Skills improvement within client teams thanks to trainings related to methodologies and tools



CAPA measures implemented


CAPA tasks


deviations addressed

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