Usage of Agile in Regulated & Compliance related domains. Application and Practical experiences of Regulated Domain Implementations. Agile Planning to Implementation.

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2. Agile in
Regulated Domains
Agile Software Development methods are
widely adopted in the software industry for
non-critical software projects. It is often
assumed Agile is not suited for regulated
domains such as:
• Aerospace
• Automotive
• Defence
• Pharmaceuticals
• Financial
• Medical Technology
• HealthCare
Agile is believed to not suit additional
requirements for extensive documentation
and detailed process compliance standards
indulged in Regulated Domains.
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3. Let us understand in detail…
There are numerous relevant standards for each regulated domain & industry that may apply
such as:
• ISO 26262 - Functional Safety standard for vehicles
• ISO 13485:2012 - Medical industry's equivalent
• AS 9100 - Aerospace industry implementation of ISO 9000/1
• ISO/IEC 15504 - Software Process Improvement and Capability Determination
• And many more…
Research of the Agile Practices indicate a potential to make development more efficient
by reducing the distance between customers, developers and testers. This is true even
in the Regulated Domains.
By using short cycles and frequent integration, tracking of progress and problems can be
enhanced, but change impact analysis can be problematic.
A big challenge is also to find an effective way of working with all the required documentation in
an incremental way, creating and updating it only when it is needed, possibly using automated
procedures. Obviously, the heavy requirements of documentation will make the work less Agile.
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4. Adoption in Regulated Domains
Reference:http://staff.lero.ie/stol/files/2013/04/ICSE2013_Fitzgerald_etal.pdf
Research in multiple industries by experts &
consultants in various regulated domains &
industries substantiate the Adoption of Agile
practice increasing evidence of Effectiveness,
Productivity and 100% Compliance to Customer,
Regulator and Market needs.
Compliance is more immediate and evident in real-
time with Agile Practice: Continuous Compliance.
Concept of Living Traceability to reflect the end-
to-end traceability and implementation of
requirements. Various toolsets has been
implemented to support the Agile Development
process.
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