pda-fda joint regulatory conference - supply chain case study rev a publish
TRANSCRIPT
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
Supply Chain Case Study:
Better Data Faster
Gerard Pearce
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
THIS SESSION• How we defined a suitable Technology Platform
• How we built a setting for Data Access & Sharing
• Lessons Learned & Best Practices
intro
history
overview
actions, methods and impact
recap
Agenda:5 10 15 20 25
future
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
quality
results
HISTORYThe Challenge: Visibility and Control
organizational
boundaries
Supplier Supplier Supplier
Supplier
Supplier Supplier
Supplier?
functional
boundaries
system
boundaries
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
HISTORYDesign Forces:
Constraints
• Budget
• Security
• Policy
Foundations
• Available Technology
• Existing Systems
• Standards
Drivers
• Client request
• Efficiency and
Connectivity
• Show KPIs
Strategic Vision
• Objectives
• Why? x5
design
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM www.sqaservices.com - "Global Quality on Demand"
OVERVIEW
Detailed Event
Status
Real-time
DashboardFiltered Program
Data
Email Alerts
Process
Controlled
Complete
Results
Data
Export
Deployed
Team
Relational Events
The result: program automation and stakeholder visibility
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM www.sqaservices.com - "Global Quality on Demand"
OVERVIEW
• Event-centric
• Crosses borders
• Links stakeholders
• Automates
processes
• „Sensitive‟
• Pushy
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
Technology/Compliance:
Perimeter Defense– Layered Firewalls
– Global monitoring
– 3rd Party Security Audits
Application Security & Validation– FDA 21cfr Part 11 Compliance
– Verisign (128 Bit SSL Encryption)
– Data Encryption (3-DES)
Open Standards
OVERVIEW
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
People– Harnessed feedback
– Pushed responsibility for data to source
– Challenged boundaries
– Promoted self-help
Tools– Used readily-available gadgets, and “stole with pride”
– Established open, web-based architecture
– Developed a „connectivity toolbox‟
– Video training
Process– Process drove system, not the reverse
– Used system to enforce business rules
– Eliminated duplicate/redundant activity
– Captured data once
ACTIONS
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
METHODSLong-term vision/roadmap
– Started with the practical, but had end game in mind
Adaptable, open philosophy– Thought through constraints and consequences
Handed over the baby– Smart make/buy decisions
Proven development approach– SDLC
– Early prototyping
– Modeling
– „Acting out‟ scenarios
diyd
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
IMPACTSystem momentum:
– In its tenth year
– Over 5,000 active user accounts worldwide
– 3,000 unique logins a month
– Over 400,000 email notifications, timesheets, password
reminders, escalations, reminders and „canned‟ reports
– 1,200 transactions a second
– Licensed to global players
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
IMPACTTypical enhancement rationale:
Time savings at each process point for Supplier Audit Program „X‟ :
– Event batch creation using the SRF screen: 15 minutes per audit x 30 audits per month
= 7.5 hours per month
– File tags, descriptions and batch loading: 10 minutes per audit x 50 audits per month =
8.3 hours per month
– CAPA creation: 1 minute per CAPA x 100 CAPAs per month = 1.7 hours per month
– Auto notifications: 5 minutes per audit x 50 audits per month = 4.2 hours per month
– CAPA approval by client: 5 minutes per CAPA x 75 CAPAs per month = 6.25 hours per
month
– Help Desk Backend Changes: 10 minutes per backend change x 20 per month = 3.3
hours per month
Total Savings: 28 hours per month at current program volume.
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM www.sqaservices.com - "Global Quality on Demand"
FUTUR
E
technology
input
review
process
system
evolution
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
RECAP & TAKE-AWAY
Defining an acceptable Technology Platform– Recognized the whole challenge
– Looked at design forces (Strategic Vision, Drivers, Foundation, Constraints)
– Understood boundaries - stayed open
Building a setting for Data Access & Sharing– Broke boundaries, simplified
– Grew a list of work-arounds (connectivity toolbox)
– Harnessed the „Human Factor‟
Lessons Learned & Best Practices– Beware silver bullets
– Standard IT rules apply
– Don‟t reinvent, steal with pride, evolve
– It‟s a tool, dummy!
www.sqaservices.com - "Global Quality on Demand"
2009 PDA/FDA JOINT REGULATORY CONFERENCE
SUPPLY CHAIN CASE STUDY - 09/15/09 3:00PM
Questions and further
information:
Gerard Pearce
310-802-4448