Project References

Industry :
Life Sciences & Chemicals

Risk & Compliance Management

The Challenge

  • A global Life Science client wanted to ensure it passed GMP* certification without any issues
  • In order to remain GMP certified, client must be ready for (surprise) inspections/ audits of all buildings involved in manufacturing operation, commercial and industrial

Avertim's approach

  • Identified key inspection risks
  • Prioritized inspection risks
  • Advised relevant parties in developing pre-prepared answers to all potential inspector questions by
  • Conducted workshops on how to act during an inspection, for eg., what to say/ not say, what type of communication style to adopt with inspectors, etc...
  • Coordinated, and was primary contact on client's behalf for key regulatory inspections and Corporate audits of Belgian sites (7 inspections in 9 months)
  • Managed responses to audit report
  • Introduced new KPIs to track effectiveness of measures

Impact and added Value

  • Client teams able to maintain compliance of site and manage inspections autonomously
  • Reduced risk of having issues on future inspections