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Integrity Solutions Europe
T.
+44 (0) 20 8793 9531
F.
+44 (0) 20 8793 9531
E.
contact@integrity-solutions.co.uk
Integrity Solutions Japan
T.
+81-3-6420-0775
F.
+81-3-6420-0162
E.
contact@integrity-solutions.co.jp
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Testimonials

"Responsive, reliable and knowledgeable.  Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"
Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

  • Preparation for pre-approval and routine regulatory inspections by global regulators

OBJECTIVES

  • Ensure readiness for external inspections in order to provide an accurate state of account and minimise risk of regulatory citation
  • Establish processes, skills and accountabilities for continuous inspection readiness

ROLE

  • Review current quality systems
  • Train client in regulatory expectations and inspection behaviour
  • Plan and execute compliance gap analysis (gap analysis, audit, review and interview)
  • Determine and prioritise gaps
  • Plan and manage remediation actions
  • Support preparation of regulatory communications
  • Support development of position papers to demonstrate current compliance status, risks and management plans
  • Provide frontline and backroom support during inspections
  • Support preparation of responses to regulatory queries and issues
  • Conduct mock inspections / audits  to evaluate state of readiness throughout programme

OUTCOMES

  • Understanding of current compliance position and risks throughout client organisation
  • Resolution of high priority risks
  • Culture of continuous readiness established
  • Increased knowledge base and confidence during inspections
  • Greater preparedness for inspections, understanding of appropriate behaviours

CHALLENGES

  • Consistent determination of risk across businesses
  • Resource commitment
  • Aggressive timescales

BENEFITS

  • Successful inspection outcomes
  • Established quality baseline, reducing future inspection preparation costs
  • Consistent compliance status across the organisation