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

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

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

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

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

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

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

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

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

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

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

Customizing/Selecting Agile Practices

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

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

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

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

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

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

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

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