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Dispensing with Agile A Holistic View on Agile in a Controlled and

Regulated Environment

Steve Messenger

Chairman DSDM Consortium

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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

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• 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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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

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Agile and Validation

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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.

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Case Study – Pharmaceutical Dispensing

• Heavily Controlled Environment

• All principles of Agile Used

• Separate Testing Phase

• System that Users Own

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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