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www.dsdm.org
Dispensing with Agile A Holistic View on Agile in a Controlled and
Regulated Environment
Steve Messenger
Chairman DSDM Consortium
www.dsdm.org
DSDM
• Evolved from RAD
• Created Collaboratively by practitioners for practitioners
• DSDM Consortium not for Profit
• Agile Manifesto Founder
• 1995 DSDM V1• 2003 DSDM V4.2• 2007 DSDM Atern• 2011 Agile PM• 2012 Agile PMO• 2014 AgilePgM• Agile BA
www.dsdm.org
• Small multi-functional team
• Work together
• Easily Communicate
• Empowered
• Focused on outcome
• Iterative and incremental approach
• Business closely and continuously involved
• Good product results
Agile works
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Complexity
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Controlled industries
5
• Regulations• Audits• Strict Quality
Procedures• Aversion to change
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www.dsdm.org
DSDM Agile Project Management
• Creating and maintaining the Prioritised Backlog
• Estimating and determining worth, budget, time
• Priority Based Planning
• Architecture and Infrastructure
• Deployment
• Repeatable, Auditable process
www.dsdm.org
www.dsdm.org
www.dsdm.org
www.dsdm.org
Agile and Validation
www.dsdm.org
Agile and Validation
Prototype and Pilot
Bespoke Programming and Configuration
DS
Business Process Definition and GMP Assessment
High Level URS
Validation Planning
Evolving DesignFDS
Installation and Operational Qualification
Des
ign
Qua
lific
atio
n (
afte
r st
epw
ise
refin
emen
t)P
RO
TO
TY
PIN
G R
EV
IEW
S
Performance Qualification
Validation Summary Reporting and Certification
Check
Check
Verify
Verify Verify
Response
Verify
Cut over
www.dsdm.org
Agile and Validation
Prototype and Pilot
Bespoke Programming and Configuration
DS
Business Process Definition and GMP Assessment
High Level URS
Validation Planning
Evolving DesignFDS
Installation and Operational Qualification
Des
ign
Qua
lific
atio
n (
afte
r st
epw
ise
refin
emen
t)P
RO
TO
TY
PIN
G R
EV
IEW
S
Performance Qualification
Validation Summary Reporting and Certification
Check
Check
Verify
Verify Verify
Response
Verify
Cut over
www.dsdm.org
Case Study – Pharmaceutical Dispensing
Active User InvolvementWhilst the previous system was validated and would dispense correctly in all cases, it was really written without much involvement from those who would use it and was actually quite difficult to use and meant we had to shoe horn our processes to fit.
This time we had the chance to make sure the system would be the best fit for us, because the people using it were the people who designed it - we were determined that the solution would come from the users.
www.dsdm.org
Case Study – Pharmaceutical Dispensing
• Heavily Controlled Environment
• All principles of Agile Used
• Separate Testing Phase
• System that Users Own
www.dsdm.org
Summary• The Agile mindset works well
• The is still a requirement for Governance and Project Management
• A full, auditable framework
• Visit stand and website
• www.dsdm.org