Sohai l Khal i d

MS Sof tware Engi neeri ng

Uni ver si ty of Management & Technol ogy, Lahore, Paki stan

AGILE IN A HIGHLY
REGULATED ENVIRONMENTS
Accepti ng the change
Work done i n Spri nt
80% of Organi zati ons fol l owi ng Agi l e





ABSTRACT
Our fri ends at wi ki pedi a say:

A regulation is 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
Seri al process

Gated entry and exi t

Documentati on, revi ew and si gnoff

Governance Hi erarchy

Mi cro management and a pl an way i nto the future

Hi ghl y resi stant to change
HIGHLY REGULATED ENVIRONMENTS
Si nce 1994 QUMAS has been del i veri ng proven regul atory,
qual i ty and compl i ance sol uti ons to :
Pharmaceutical
Biotechnology
Medical device
Address gl obal regul atory chal l enges across the l i fecycl e of:
Product research
Development
Manufacturing
Corporate compliance
QUMAS
Agi l e methods and regul ated envi ronments are often seen as
fundamental l y i ncompati bl e. The reason for thi s can be traced
to the Agi l e Mani festo



AGILE & REGULATED INCOMPATIBILITY
KEY CONCEPTS IN REGULATED
ENVIRONMENTS
SCRUM
SCRUM PROCESS
R-SCRUM
R-SCRUM
QA bought i n to agi l e process (despi te fundamental change i n
work confi gurati on)
Formal conformance audit of every Sprint completed within three
days of end of Sprint (~every three weeks)
Non-conformance report fed back to Backlog
Conti nuous Compl i ance
No unexpected surprises at final release. We are just confirming the
final release VP Quality & CRM
Qual i ty
Agi le 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
Fi nding i n 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)
Safety & Security
Agi le Says
Agile thought to lack formal planning, risk mitigation.
Fi nding i n R- Scrum
Continuous compliance
Risk also mitigated by risk prioritizationtackling the most significant
risks first.
KEY FINDINGS(SAFETY & SECURITY)
Ef fectiveness
Agi le Says
Adherence to regulations and standards slows down development process
and delivery speed to customer
Fi nding i n R- Scrum
Frequent releases enable pre- sales and early delivery 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 link between development,
documentation and support.
Always up- to- date sales & marketing material .
KEY FINDINGS(EFFECTIVENESS)
Traceabi li ty
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 are much
shorter and done without key staff
KEY FINDINGS(TRACEABILITY)
Traceabi li ty
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)
There i s compl ete transparency i nto the devel opment
process at any poi nt i n ti me.

LIVING TRACEABILITY
Overal l , the agi l e devel opment process as i t has been adopted
and augmented i n QUMAS has worked very wel l i n the
regul ated envi ronment
Compl i ance i s more i mmedi ate and evi dent i n real -ti me
Concept of living traceability has been coi ned to refl ect the
end-to-end traceabi l i ty that has been faci l i tated by the tool set
that has been i mpl emented to support the agi l e devel opment
process
assumpti on of i ncompati bi l i ty between agi l e methods and
regul ated envi ronments i s more accidental than essential

CONCLUSION
Conduct further case studi es i n other regul ated domai ns
Extend the study i n parti cul ar XP
Quanti tati ve Study of Agi l e
FUTURE WORK
Fitzgerald, Klaas-Jan Stol , Ryan O' Sullivan, and Donal O' Brien
Scal i ng Agi l e Methods to Regul ated Envi ronments ICSE 2013
M. Fowl er and J. Hi ghsmi th, The agi l e mani festo, Software
Development, vol . 9, pp. 2832, 2001.
P. Abrahamsson, K. Conboy, and X. Wang, l ots done, more to
do: the current state of agi l e systems devel opment research,
European Journal of Information Systems, vol. 18, 2009.
O. Cawl ey, X. Wang, and I. Ri chardson, Lean/agi l e software
devel opment methodol ogi es i n regul ated envi ronmentsstate
of the art, i n Intl Conf. Lean Enterprise Software and
Systems, LNBIP 65, 2010

REFERENCES


Questions are welcome for our
learning.
sohai l khal i d@hotmai l . com
QUESTIONS ?