Integrated Assurance Case Study

Business Case Working with a Global IT operation with complex needs.

• multiple IT / IS Quality Management Systems
• Different IT/IS organisations and processes addressing GxP, SOX, Data Privacy, Security
• Different GxPs in operation

The business risk profile varied across the IT/IS customer base which included, but were not exclusively Marketing, R&D, Manufacturing and Finance.

Strategy

An in-depth exploration of opportunities, benefits and risks of implementing a fully integrated and streamlined approach.

• Explore opportunities for greater balance of quality; vs. compliance
• Ensure sustainable solution based on maturity management
• Benchmark against like organisations

Execution

We carried out a programme of data gathering interviews at all levels and areas of the customer base, including quality functions, IT/IS leadership and IT/IS service delivery personnel. We then held workshops to analyse the feedback from interviews and benchmarking. We delivered improvement proposals (AIMS, Risks, Benefits, Approach) and plans to IT/IS Leadership.

Outcome

The results were impressive, both at a practical business process level, and a interdepartmental relationship level

• A refinement of governance structure and accountabilities
• Integrated processes addressing GxP, SOX, Data Privacy, Security
• Common IT QMS
• Quality controls scaled to risk profile
• QMS foundation built on existing policies, standards and processes
• New cross functional, cross 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

KPIs and Benefits

• Rationalisation of support systems, for example 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

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