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Case Studies

BACKGROUND

• 1, 2 and 3 day training programmes for IT professionals, business users, business quality
• Quality “culture” low in maturity
• Quality viewed as a constraint to creative thinking

OBJECTIVES

• Establish an understanding of “Risk Based” validation
• Clear fog of quality myths and legends
• Introduce scaleable approach
• Develop understanding of relationships between Good IT Practice and Validation

APPROACH

• Seek feedback on expectations and concerns prior to training
• Included interactive workshop for each topic
• Developed understanding of Good IT Practice controls prior to introducing CSV concepts
• Related all topics to patient, regulatory and business risk
• Provided examples of scalable approach throughout 

OUTCOMES

• Attendees no longer feel constrained and offer improvement ideas for current CSV processes
• Greater upfront planning of CSV activities
• CSV integrated into overall project activities
• Validation deliverables add value to organisation

CHALLENGES

• Gaining appreciation business vs. IT accountability
• Organisation management recognising the cultural changes required to move forward

BENEFITS

• Validation costs significantly reduced
• Documentation is maintained as it adds value to the services provided by IT
• Business roles vs. IT roles more clearly defined and owned by rightful owners

EXAMPLE 2 DAY PROGRAMME

DAY 1

09:00 09:30 Intro and determination of what the delegates want/expect
09:30 10:00 Laws, Regulations and Business Drivers for CSV
10:00 10:45 GAMP 5 ® An Industry Approach to CSV
10:45 11:00 BREAK
11:00 11:45 Risk Management
11:45 12:30 WS: Risk Management
12:30 13:15 LUNCH
13:15 14:00 Effective User Requirements
14:00 14:45 WS: Infrastructure Qualification
14:45 15:00 BREAK
15:00 15:45 Infrastructure Qualification
15:45 16:30 Supplier Assessment
16:30 17:15 WS: Supplier Assessment

DAY 2

08:30 09:15 E-records and signatures
09:15 10:00 WS: Outline a Validation Strategy
10:00 10:30 Validation Planning
10:30 10:45 BREAK
10:45 11:15 Specifications, Design Review and Traceability
11:15 12:00 Protocols and Testing
12:00 12:45 WS: Planning testing
12:45 13:30 LUNCH
13:30 14:15 Change Management
14:15 15:00 WS: Change Management
15:00 15:30 Validation Reporting and Presentation to Inspectors
15:30 15:45 BREAK
15:45 16:15 Data Migration
16:15 17:00 Maintaining Control in Operation
17:00 17:15 Wrap Up

WS: Workshop