BACKGROUND
Globally, ensure compliance of all computerised systems with current regulatory expectations
Business, process, laboratory & clinical systems
R&D, Manufacturing, Distribution and Pharmacovigilance
OBJECTIVES
- Maximise business value from retrospective effort e.g. greater process /system understanding, reduced operation and maintenance costs
- Knowledge transfer ensuring client is self sufficient post project
- Establish infrastructure for future cost effective validation
ROLE
- Establish and manage integrated project team comprising client and ISL resource
- Train client organisation in current regulatory requirementsEstablish risk based quality, CSV, ERES, Infrastructure, Security policies / standards.
- Implement gap analysis toolset
- Establish “expert circle” to ensure consistency and resolve issues
- Cross site audits to ensure consistency of assessments and risk
- Establish and execute risk based plans to remediate systems
OUTCOMES
- Minimum documentation set established for all systems
- Critical functions and performance criteria determined and tested
- Quality processes for ongoing management of systems established
- Clarity of accountabilities for CSV and operation established
- Systems rationalised where possible
CHALLENGES
- Establishing a consistent perspective of risk across business functions, regions and sites
- Securing dedicated client resource
- Maintaining priority against other business improvement initiatives
- Securing investment into extensive training programme
BENEFITS
- Successful regulatory inspections post project
- Greater understanding of processes and patient risks
- Lower prospective validation costs through adoption of risk based approach, integrated validation, knowledge and clarity of accountabilities
- Greater control over system maintenance