BACKGROUND
Global pharmaceutical operation
Disparate quality systems
Limited quality culture across organisation
Complex IT quality governance structure
OBJECTIVES
- Develop understanding of industry practice and regulatory expectations (e.g. GAMP®, ITIL®, PIC/S, SOX)
- Establish quality policies, standards and processes in response to business & IT strategy, external laws and regulation
- Establish simplified IT quality governance structure
- Effective and efficient processes that operate globally
ROLE
- 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
OUTCOMES
- 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
CHALLENGES
- Promoting operational effectiveness over regulatory compliance
- Integrated processes addressing GxP, SOX, Data Privacy & Security
- Different perceptions of regulatory expectations across regions and organisations
- Gaining commitment of resources to develop processes
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