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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