1. Case Study: Leveraging TrackWise Web Services and Best Practices in Global Change Control
Perrigo Global Change Control Case
Tami Frederick, Perrigo Global Director, Corporate Quality Systems
Lisa DeSmet, Perrigo Global Quality Systems Program Manager
Kevin Seckel, Perrigo IT Applications Manager
Biswanath Majumdar, Perrigo IT Applications Engineer
Brian Brzezinski, Sparta Solutions Consultant

2. Learn, Network and Enhance your Quality Career
Today’s Program Will Deepen Your Learning
In the Underlined BOK Topics Below
Common Elements:
Team Development
Quality Culture & Philosophies
Process Management Fundamentals
CMQ&OE:
Leadership; Managing Staff
Strategic Planning of Quality
Quality Systems
Customer Focus
Supplier Management
Lean Six Sigma:
Lean Methodology
Project Selection & Charters
DMAIC & DMADV
Basic Tools & DOE Problem Solving SIPOC, CTQ & Other LSS Tools
CQE:
Quality Systems & QC Methods
Design QA (Verify, Validate)
Statistics, DOE Tools & SPC
Product Reliability Engineering
Document & Tool Control
CQA:
Auditor Principles & Ethics
Planning Audits
Conducting Audits
Audit Reporting
Lead Auditor Role
Interested in local certification prep courses? Contact our Education Chair – Tim King

3. Global Change Control Initiative at Perrigo
AGENDA
Global Change Control Initiative at Perrigo
Leveraging TrackWise Web Services
Best Practices - TrackWise Web Services
Questions

4. Global Change Control Initiative at Perrigo
Why we need Global Change Control
How GCC was Designed
The GCC Process
Business Process Transformed in Prototype

5. Why Global Change Control?
Changes Impacting Multi-Sites
Consistent Global Process, Visibility & Metrics
Need Global Change Control
Changes Impacting Multi-Markets
Changes Impacting Contract Customers TM

6. Global Change Process Improvements
One Global Change Process
Consistent Change Types
Global Filter tool
Global & Local Review
Global Change Review Board
Global & Local Metrics and Reporting
Continuous
Improvement TM

7. Global Change Control System
Global Case Encompassing all Sites Impacted
Full Workflow for all cases
Local Change Control
Individual Case for each site
May be used as stand alone local system
Legacy Change Control
Global System links to Legacy Change Control System for more detail
Legacy system may be used for local changes
Change Tasks
Auto-creation of change plan and tasks TM

8. Best in Industry Global Change Control FeaturesWS WS
Unique GCC Features
Global Filter: for Site, Market, Contract (Automated)
Interface: to SAP and to Global Regulatory Database
Related Changes: Automated look-up for any change control for same product
Auto Creation of Change Tasks
Best in Class Reporting & Dashboards at Global and Local Level
Improved Global Visibility and Governance WS WS TM

9. Leveraging TrackWise Web Services
3 separate web services
Global filter
Finding related changes
Auto creation of child tasks

10. Global Filter
Identify where product is produced, sold, and who else do we make product for
Product
Manufacturing
Contract
TrackWise
Product
Manufacturing
Contract
Market
SAP
Product
Code
Data List
123
Web Services 1
GRAPALL System
Product
Manufacturing
Market
Assessment Grid
500+ Records
Summary Records

11. Find Related Changes Search all instances of TrackWise
for Open Cases against Product Code
Open Cases
Local
CHG MGMT
System
Process
Materials
Equipment
GRAPALL System
TrackWise
Product
Code
123
Web Services 2
Open Cases
Web Services 1
Global
CHG MGMT
System
Global Change
Local Change
All Open Cases

12. Auto Creation of Child Tasks
Owner of change will create list of all tasks required to complete change
TrackWise
Triggers workflow
Web Services 3
Each row :
Creates child tasks (separate case)
Posts activity in local change record (notification)
Family Tree

13. Best Practices - TrackWise Web Services
Product lookup functionality
Bulk product code entry
Summary field
Inbound Web Services

14. Product Lookup functionality
Web Services
Product Code
Operation: SearchProduct
SOAP XML Message
SAP
List of Matching Products
SOAP XML Message
SAP RFC
Selected Product Code
Error Handling –
Product Not Found
System Unavailable
SOAP XML Message
GRAPaLL
Features:
Users can search on partial Product Code value
SAP RFC simplifies extraction of Product information
JDBC
Operation: SelectProduct
Product Information
SOAP XML Message

15. Bulk Product Code Entry
Web Services
SAP
Operation: AddBulkProducts
SAP RFC
Bulk Product Codes
SOAP XML Message
Error Handling –
Product Not Found
System Unavailable
GRAPaLL
JDBC
Features:
Need to enter Exact Product Codes
Add multiple Product Codes through Multi-Text field
Perform Assessment for all Products at once
Product Information
SOAP XML Message

16. Summary Fields Features :
SOAP XML Message
SAP
Features :
Helps user to perform assessment by providing -
What Products are impacted
What Sites are impacted
What Markets / Contracts are impacted
Web Services
Operations:
SelectProduct
AddBulkProducts
RefreshAssessment
SAP RFC
GRAPaLL
SOAP XML Message
JDBC

17. Operation: CreateChildren Operation: RelatedChanges
Inbound Web Services
Web Services
Operation: CreateChildren
Create Children
(Every 2 mins)
Searches in the Change Plan Grid
Creates Children Tasks
Updates Grid with Task Case ID#
Posts activity on Local Change
Quartz
Scheduler
Operation: RelatedChanges
Searches for Open Local Changes
Updates Local Changes with relevant Product Codes
Related Changes
(Every 5 mins)
*Scheduled background process that uses the application user account to perform the following tasks

18. Questions?