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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
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+81-3-6420-0775
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+81-3-6420-0162
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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

  • Supplier, Organisation, Project Assessments
  • Range of suppliers, projects and organisations (computerised systems, IT service providers, engineering organisations, R&D and manufacturing, pharma, medical device, biotech, cosmetics, process industries)
  • Evaluation of shortfalls and risks, remediation planning
  • Review and / or execution of remediation activities

OBJECTIVES

  • Plan and execute supplier, organisation, project  assessments
  • Train internal personnel in assessment / inspection planning, execution, reporting and risk assessment methods
  • Manage assessment programme
  • Conduct assessments globally
  • Identify critical risks and value added remediation actions

ROLE

  • Custom and off-the-shelf assessment training programmes
  • Determination of business, patient and regulatory risks impacting client organisation
  • Plan assessment schedule and determine appropriate form of assessment (review, on site audit, postal audit, project learning)
  • Lead assessments, supporting and / or mentoring client personnel
  • Facilitate risk assessments, plan remediation and support review and execution of high risk preventive / corrective actions

OUTCOMES

  • Improved quality systems, processes and skills
  • Improved customer / supplier relationships
  • Greater leveraging of effort from internal and external supply organisations
  • Improved external inspection readiness

CHALLENGES

  • Understanding of audit value, reduced lifecycle costs
  • Establishing consistent risk tolerance across business functions
  • Remediation action follow up and closure

BENEFITS

  • Utilisation of capable, experienced suppliers
  • Reduced project costs, risk reduction, avoid duplication of effort, improved control over lifecycle activities
  • Improved customer / supplier relationships
  • Client’s self sufficient post ISL support