1. UA Online PMDAY 2021
Making Agile Easier
Coaching the Enabling Organizations for Agile
Transformation
Mike Palladino, PMP, CSM, ATP Instructor, SAFe
- Director, Agile Center of Excellence, Bristol Myers Squibb
- Adjunct Professor, Villanova University
- Author, Data Management University
- Past President, PMI-DVC chapter

2. Context
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Agile
Teams
Procurement
Validation Security
Human
Resources
Legal
Finance
Enabling
Organizations

3. • Procurement • Finance • Validation
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Who Will be Impacted

4. PROCUREMENT
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5. 5
Compare the Approaches for Contracts
Traditional Contract Agile Contract
List all deliverables.
A lot of detail
Only high-level deliverables.
Define process to develop details
Focus on disagreements & penalties Focus on collaboration
Lack of trust Requires trust and grows trust
Focus on only this contract Focus on future work as well as this contract
Contract dates are defined. Difficult
to adjust
May finish sooner or later than original date.
Both sides share the risk
Hard to incorporate change Easy to incorporate change
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6. New Approach – Key Elements
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• Master Service Agreement (MSA)
• Separate from deliverables
Separate
• Keep scope at high level
• Not detailed deliverables
Scope
• Define process
• Not detailed deliverables
Process
• High Level Acceptance
Acceptance
• Not Fixed Price
Time & Material
• Share the benefits
• Share the losses
Share

7. On-going Cycles
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Review
Q1
Create
Q2
Review
Q2
Create
Q3
Review
Q3
Create
Q4
Review
Q4
Create
Q1
Year 1
Year 2
12/2020
Create
Q1
3/2021 6/2021 9/2021 12/2021
Review
Q1
Create
Q2
3/2022
…
Continue

8. Additional Information
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Design an Agile Contract
• https://www.villanovau.com/resources/contract-management/how-to-design-an-
agile-contract/
• Allow changes
• Transparency is key
• Leave room for updates
Agile Contracts Primer
• https://agilecontracts.org/agile_contracts_primer.pdf
• Written for lawyers and Agile practitioners
• Derived from the book... Practices for Scaling Lean & Agile Development:
Large, Multisite, & Offshore Product Development with Large-Scale Scrum
• by Tom Arbogast, Craig Larman, and Bas Vodde

9. FINANCE
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10. Typical project with depreciation
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$4M $4M $4M
Benefits
- Spread out the expense
- Offset future income
- Saves taxes
2 Year Project $12M
3-year depreciation
1/3 each year = $12/3 = $4M
Year 1 Year 2
Year 3 Year 4 Year 5

11. Typical project with depreciation
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$4M $4M $4M
2 Year Project $12M
Year 1 Year 2
Year 3 Year 4 Year 5
Problem
- Capital/expense ratio is different
- Can impact perceived company value
$12M
All expense in Year 2
Project Canceled
X X X

12. Financial Impact of Rapid Releases
12
Waterfall
Agile
Start
Release
Begin depreciation
Start
Releases
Partial depreciation for each release

13. Financial Impact of Rapid Releases
13
Agile
Start
Releases
$
$
$
Per Release
- Labor costs
- Material costs

14. VALIDATION
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15. 15
What is validation
What is software validation
Documented evidence that confirms a computer
has been installed correctly and functions
according to its intended use
It works
It works as designed
How to Validate
Record evidence that shows the system was
installed and works as intended
Inspect before software is ran
Inspect while software is running
Actual FDA requirements
Must meet the FDA’s
standards for production
and inventory management
Every step of the
validation process must
be documented
Typically, people run Test Scripts and
take screen captures of each step. Not
effective nor fast.
What is the FDA
Federal Drug Administration
United States government organization that
confirms drugs and medical devices are safe
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16. Validation Plan
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Validation
1 Create Validation Plan
2 Define System Requirements
3 Create Validation Protocol & Test Specifications
4 Testing
5 Develop/Revise Procedures & Final Report

17. Waterfall
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18. Agile end-to-end use in validated environments
18
Red - No formal effort
in place
Orange - Efforts in
early stages
Yellow - In place in
pockets
Green - In place with
wide use
Solution Life
Cycle (SLC)
Computer System
Validation (CSV)
Tool
Integration
Automated
Testing
DevOps SecOps (or
DevSecOps)
Use of User Stories
for Validation
Risk-based
Validation
IT Quality Management
support for Agile
Enterprise Quality
Management
support for Agile
Auditors support
for Agile
Many pieces must
come together
O O Y
O
R
O
R
G
Y
R
Y

19. Validation Analogs
19
Batch
manufacturing
Agile
Waterfall
Recipe Make Test Sell
Requirements Build Test Release
Concept Experiment & Test Release
New and Unique
Dessert and
Secret Ingredient
Accept
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20. What to Validate
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Feature
Epic
Feature Feature
Story Story Story Story Story Story Story
Validate

21. Conclusion
• As Agile continues to grow, supporting
organizations will need to change, too
• Help them understand Agile
• Learn enough of their business to understand
the impact
• Organizations have been generally positive
• Find someone who is willing to work with you
21
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22. UA Online PMDAY 2021
Thank you!
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