1. Adapting Agile in Pharmaceutical Industries
Submitted By
Prachiben Shah
GRAD 699/Late Summer

2. Agenda Introduction Agile Vs Waterfall
Why Agile? Benefits and Challenges
Problem Statement
Research Approach
Results and Findings
Discussion –Future study
Conclusion

3. Waterfall Traditional Methodology Suitable for Complex Projects
Clear Scope
Requirements are not changed Frequently
Finish to Start Approach
Step by step approach

4. Changes happen at early stage
Agile
Requirements change
Design evolve
Feedback welcome
Changes happen at early stage
Time boxed activities
Less documentation

5. Agile Benefits Improve quality Risk management Empowers the system
Get the clear picture of actionable items
Transparency
Focuses on Business Value and customers
Early predictable delivery
Increase Project Control
Agile Benefits

6. Challenges Regulatory Complexity of software development
Difference between agile and Documentative Approach
Lack of Attempts
Lack of Knowledge
Resistance to change
Challenges

7. Problem Statement Resistance to Changes
Pharmaceutical Projects connect with People Safety
Agile Avoids planned documents and process
Myth-FDA suggests waterfall

8. Goal Approach to eliminate factors and make easier adaptation process
Explore possibility of agile in Pharmaceutical Setting
Solution to challenges
Planning
Educate People and awareness
Regulatory Requirement :
Quality Process
Quality Product
Quality Documentation

9. Research Approach
Keyword Search: articles, Journals, eBooks, Blog posts
Strategic plan
Comparison Two approaches
Choosing Agile Approach
Mapping regulatory activities
Results and Findings
QA activities
Future Studies

10. Result/Findings: Adaptation Approach
Activities/Approach to adapt agile in pharmaceutical environment
Planning
Gather Insights
Agile principles and its interpretations
Choosing and/or customizing agile approach
Mapping regulatory activities to agile practices
Benefits of customized approach
Balancing conflicts
Alternatives for conflicts
Requirement Management
Documentation
Importance of Documentation Requirement
Define/Introduce quality stages to ease documentation
QA activities (Role)
Training
Communication
Collaboration
Flexibility
Automation

11. Agile Interpretation Agile Principles/Manifesto Interpretation
Value individuals and interactions over processes and tools
Robust Processes
Working software over comprehensive documentation
Documents
Customer collaboration over contract negotiation
Processes
Responding to change over following a plan
Individuals and interactions
Roles

12. Customizing/Selecting Agile Practices

13. Hardening Sprints Formal testing Record Verification –Document
Synchronization activities
Formal Document approval
Review

14. Requirement management (Documentation)
Deliverables produced from Hardening Sprints
Iterative activities
Documentation Deliverables
Release Planning
Update Project Plan
Architect Analysis
Compose Estimate Future Stories
Story Design
User Story-Design evaluation
Story design approval
Update system architecture and system protocol
Add to Requirement Document and traceability Matrix
Write- Test-Develop
Update Design Document and Traceability
Demo
Document Design Review
Acceptance testing
Update Test report and test suite
Retrospective
Update Software Development Plan

15. Conflicts Requirements Change Requirements from Old system
Team members working differently
Decision not communicated

16. Balancing Conflicts
Just enough design input rather than completing design input
Parallel activities
Finish to finish approach
Synchronization point in between design input and output.
Timeboxed synchronization point

17. QA Activities Training Change of thinking Communication Collaboration
Flexibility
Focus on end product
Integrate Tool
Automation

18. Discussion Success Story- Griffols Automated Tool
Other Regulatory industries
Limited Research Articles
Customized approach

19. Further Study In detailed Study and Surveys
Research in other documentative industries
Real world scenario

20. Conclusion Agile principles adjacent to regulations requirements
Customized approach
QA participation
Selection of Tools
Automation
Possible to adapt