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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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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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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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