Agile Methodology in Regulated Environments

8/12/2019 Agile Methodology in Regulated Environments

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Sohail Khalid

MS Software Engineering

University of Management & Technology, Lahore, Pakistan

AGILE IN A HIGHLY

REGULATED ENVIRONMENTS


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Accepting the change

Work done in Sprint

80% of Organizations following Agile

ABSTRACT


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Our friends at wik ipedia say:

A regulationis a rule or law designed to control or govern conduct .

Regulation creates, limits, constrains a right, creates or limits a duty,

or allocates a responsibility.

REGULATION


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Serial process

Gated entry and exit

Documentation, review and signoff

Governance Hierarchy

Micro management and a plan way into the future

Highly resistant to change

HIGHLY REGULATED ENVIRONMENTS


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Since 1994 QUMAS has been delivering proven regulatory,

quality and compliance solutions to :

Pharmaceutical

Biotechnology

Medical device

Address global regulatory challenges across the lifecycle of:

Product research

Development

Manufacturing

Corporate compliance

QUMAS


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Agile methods and regulated environments are often seen as

fundamentally incompatible. The reason for this can be traced

to the Agile Manifesto

AGILE & REGULATED INCOMPATIBILITY


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KEY CONCEPTS IN REGULATED

ENVIRONMENTS


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SCRUM


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SCRUM PROCESS


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R-SCRUM


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R-SCRUM

QA bought in to agile process (despite fundamental change in

work configuration)

Formal conformance audit of every Sprint completed within three

days of end of Sprint (~every three weeks)

Non-conformance report fed back to Backlog

Continuous Compliance

No unexpected surprises at final release. We are just confirming the

final release VP Quality & CRM


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Quality Agile Says

Time-to-market is a key constraint recognized by agile methods and the

concept of delivering good enough working software in an optimum

timescale takes precedence over perfect software Finding in R-Scrum

Product, release and sprint backlogs constantly validated with developers

and customers.

Continuous integration and systematic refactoring.

QA function very supportive of agile process believing benefits outweigh

inconvenience of changes to traditional working practices

KEY FINDINGS(QUALITY)


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Safety Security Agile Says

Agile thought to lack formal planning, risk mitigation.

Finding in R-Scrum

Continuous compliance Risk also mitigated by risk prioritizationtackling the most significant

risks first.

KEY FINDINGS(SAFETY & SECURITY)


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Effectiveness Agile Says

Adherence to regulations and standards slows down development process

and delivery speed to customer

Finding in R-Scrum Frequent releases enable pre -sales and early deliver y to customer.

Ability to rapidly respond to customer change request within 5 weeks.

Active management allows the Scrum Master to correct course on a daily

basis.

Updates are visible in real time to all team members.

Documentation person to ensure a l ink between development,documentation and support.

Always up-to-date sales & marketing material .

KEY FINDINGS(EFFECTIVENESS)


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Traceability Agile Says

Lack of attention to documentation in agileinhibits traceability.

Finding in R-Scrum

Powerful toolset providing extensive and automatic living traceability. Impact assessment of changes are easier to identify via the automated

traceability.

QA conducts internal audits much more often; external audits ar e much

shorter and done without key staff

KEY FINDINGS(TRACEABILITY)


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Traceability Agile Says

Requirements specification is time consuming.

Finding in R-Scrum

Continuous integration supported by powerful toolset. Automated tests and automatic link to code facilitate easy coverage

reporting

KEY FINDINGS(VERIFICATION &

VALIDATION)


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There is complete transparency into the development

process at any point in time.

LIVING TRACEABILITY


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Overall, the agile development process as it has been adopted

and augmented in QUMAS has worked very well in the

regulated environment

Compliance is more immediate and evident in real-time

Concept of living traceability has been coined to reflect theend-to-end traceability that has been facilitated by the toolset

that has been implemented to support the agile development

process

assumption of incompatibility between agile methods and

regulated environments is more accidental than essential

CONCLUSION


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Conduct further case studies in other regulated domains

Extend the study in particular XP

Quantitative Study of Agile

FUTURE WORK


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Fitzgerald, Klaas-Jan Stol, Ryan O'Sullivan, and Donal O'Brien

Scaling Agile Methods to Regulated Environments ICSE 2013

M. Fowler and J. Highsmith , The agile manifesto, Software

Development, vol. 9, pp. 2832, 2001.

P. Abrahamsson, K. Conboy , and X. Wang, lots done, more todo: the current state of agile systems development research,

European Journal of Information Systems, vol. 18, 2009.

O. Cawley, X. Wang, and I. Richardson, Lean/agile software

development methodologies in regulated environmentsstate

of the art , in Intl Conf. Lean Enterprise Software andSystems, LNBIP 65, 2010

REFERENCES


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Questions are welcome for our

learning.

[email protected]

QUESTIONS ?

Documents

Agile Methodology in Regulated Environments