Effective risk-based compliance services

Effective risk based compliance services

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Life Sciences companies are facing increased pressure to implement and sustain compliant –and even regional or global- solutions, this in an increasingly inter-related supply chain environment, including challenging supporting IT infrastructure and processes.

The traditional validation response is no longer appropriate, particularly due to the complexity of solutions delivered, the interdependence of functionalities and systems to be considered. The need for a pragmatic, standardised, cost effective, risk-based, benefits driven approach and robust post go live supporting processes is re-enforced.

PwC has extensive experience of effective risk-based validation and connects over 2100 pharma specialists in 90 countries. PwC works with clients to:
 

  • Set up the right project framework(e.g. selection of supporting tools and methodology)
  • Define a best pragmatic, cost effective, integrated compliance strategy and the underlying project structure
  • Drive jointly resources towards successful delivery of a compliant and sustainable solution
  • Integrate all the required IT infrastructure qualification activities (even when being outsourced or offshored)
  • Work jointly with client resources to accelerate knowledge transfer
  • Plan and communicate effectively and efficiently between global, regional, local, and external stakeholders
  • Assess proactively their compliance readiness prior to the launch of highly regulated, business critical programs