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.
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
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.
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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