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Integrity Solutions Europe
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+44 (0) 20 8793 9531
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+44 (0) 20 8793 9531
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contact@integrity-solutions.co.uk
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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

  • Global IT operation working to multiple IT / IS Quality Management Systems
  • Different IT/IS organisations and processes addressing GxP, SOX, Data Privacy, Security
  • Business risk profile varied across IT/IS customer base (Marketing, R&D, Manufacturing, Finance).  Also operating to different GxPs.

OBJECTIVES

  • Explore opportunities, benefits and risks of a more integrated approach
  • Explore opportunities for greater balance of “quality” vs. “compliance”
  • Ensure sustainable solution based on maturity management

ROLE

  • Interview customer base, quality functions, IT/IS leadership and IT/IS service delivery personnel
  • Benchmark against like organisations
    Workshops to analyse feedback from interviews and benchmarking
  • Improvement proposals (AIMS, Risks, Benefits, Approach) and plans to IT/IS Leadership

OUTCOMES

  • Refinement of governance structure and accountabilities
  • Integrated processes addressing GxP, SOX, Data Privacy, Security
  • Common IT QMS.  Quality controls scaled to risk profile

CHALLENGES

  • QMS foundation built on existing policies/standards/processes
    Cross functional / discipline teams
  • Engagement of IS/IT leadership and business quality functions
  • Accountabilities matched by authority
  • Relationships with ongoing parallel business improvement initiatives
  • Synchronisation of QMS implementation & existing QMS decommissioning

BENEFITS

  • Rationalisation of support systems e.g. Incident Management, Risk Management, Document Management, Process Management
  • Increased portability of solutions across business boundaries
  • Increased mobility of resources across business boundaries
  • Different maturity targets to match customer risk profile
    Process improvements based on metrics and business case