IT Infrastructure Compliance

Business Case 

We worked with a global pharmaceutical operation with disparate quality systems and limited quality culture across the organisation, and a complex IT quality governance structure. We had to overcome some challenges including:

• Promoting operational effectiveness over regulatory compliance
• Integrated processes addressing GxP, SOX, Data Privacy and Security
• Different perceptions of regulatory expectations across regions and organisations
• Gaining commitment of resources to develop processes

Strategy 

We needed to develop and establish:

• An understanding of industry practice and regulatory expectations (e.g. GAMP®, ITIL®, PIC/S, SOX) within the business
• Quality policies, standards and processes in response to business and  IT strategy, external laws and regulation
• A simplified IT quality governance structure

Above all, we implemented effective and efficient processes that operate globally.

Execution

This project required excellent management, communication and training programmes.

• Management workshops to raise awareness of industry practice and regulatory expectation
• Technical training of IT personnel
• Gap analysis of existing QMS’ to leverage current best practice
• Workshops defining new governance structure and IT processes
• Manage SME process development teams
• Gap analysis and remediation of quality records against implemented policies, standards and processes
• Manage Service Desk, EDMS, Training Management systems

Outcome

The desired outcomes were achieved:

• Clarity of IT quality and business quality roles and relationships
• Common IT standards and processes across IT organisation
• Qualified IT infrastructure
• Implemented and validated support systems
• IT knowledge of industry standards and regulations increased

KPIs and Benefits

• Effective “global” IT processes through use of automated systems (e.g. Service Desk, EDMS, Training Management)
• Shorter infrastructure project timescales and fewer service calls
• Greater resource mobility
• Significantly improved outcome of compliance audits

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