Editing Agile software development (section)

=== Regulated domains ===
Agile software development methods were initially seen as best suitable for non-critical product developments, thereby excluded from use in regulated domains such as [[medical device]]s, pharmaceutical, financial, nuclear systems, automotive, and avionics sectors, etc. However, in the last several years, there have been several initiatives for the adaptation of agile methods for these domains.<ref name="Cawley2010">{{Cite book|date = 2010|isbn = 978-3-642-16415-6|pages = 31–36|series = Lecture Notes in Business Information Processing|volume = 65|first1 = Oisín|last1 = Cawley|first2 = Xiaofeng|last2 = Wang|first3 = Ita|last3 = Richardson| title=Lean Enterprise Software and Systems | chapter=Lean/Agile Software Development Methodologies in Regulated Environments – State of the Art |editor-first = Pekka|editor-last = Abrahamsson|editor2-first = Nilay|editor2-last = Oza|doi=10.1007/978-3-642-16416-3_4|hdl = 10344/683}}</ref><ref name="McHugh2014">{{Cite book|date = 2014-11-04|isbn = 978-3-319-13035-4|pages = 190–201|series = Communications in Computer and Information Science|volume = 477|first1 = Martin|last1 = McHugh|first2 = Fergal|last2 = McCaffery|first3 = Garret|last3 = Coady| title=Software Process Improvement and Capability Determination | chapter=An Agile Implementation within a Medical Device Software Organisation |editor-first = Antanas|editor-last = Mitasiunas|editor2-first = Terry|editor2-last = Rout|editor3-first = Rory V.|editor3-last = O'Connor|editor4-first = Alec|editor4-last = Dorling| display-editors = 3|doi=10.1007/978-3-319-13036-1_17|url = https://arrow.dit.ie/cgi/viewcontent.cgi?article=1152&context=scschcomcon}}</ref><ref>{{Cite book|last1=Wang|first1=Yang|last2=Ramadani|first2=Jasmin|last3=Wagner|first3=Stefan|title=Product-Focused Software Process Improvement |chapter=An Exploratory Study on Applying a Scrum Development Process for Safety-Critical Systems |date=2017-11-29|series=Lecture Notes in Computer Science|language=en|volume=10611|pages=324–340|arxiv=1703.05375|doi=10.1007/978-3-319-69926-4_23|isbn=9783319699257|bibcode=2017arXiv170305375W|s2cid=4585465}}</ref><ref name="SafeScrum">{{cite web|url=http://www.sintef.no/safescrum |title=SafeScrum - SINTEF |publisher=Sintef.no |access-date=2019-03-26}}</ref><ref>Thor Myklebust, Tor Stålhane, Geir Kjetil Hanssen, Tormod Wien and Børge Haugset: Scrum, documentation and the IEC 61508-3:2010 software standard, http://www.sintef.no/globalassets/ec-61508-documentation-and-safescrum-psam12.pdf</ref>

There are numerous standards that may apply in regulated domains, including [[ISO 26262]], [[ISO 9000]], [[ISO 9001]], and [[ISO/IEC 15504]].
A number of key concerns are of particular importance in regulated domains:<ref name="Fitzgerald2013">{{Cite book|date = May 2013|pages = 863–872|doi = 10.1109/ICSE.2013.6606635|first1 = B.|last1 = Fitzgerald|first2 = K.-J.|last2 = Stol|first3 = R.|last3 = O'Sullivan|first4 = D.|last4 = O'Brien| title=2013 35th International Conference on Software Engineering (ICSE) | chapter=Scaling agile methods to regulated environments: An industry case study |isbn = 978-1-4673-3076-3|hdl = 10344/3055|s2cid = 192403}}</ref>

* [[Quality assurance]] (QA): Systematic and inherent quality management underpinning a controlled professional process and reliability and correctness of product.
* Safety and security: Formal planning and risk management to mitigate safety risks for users and securely protecting users from unintentional and malicious misuse.
*[[Traceability]]: Documentation providing auditable evidence of regulatory compliance and facilitating traceability and investigation of problems.
* [[Verification and validation]] (V&V): Embedded throughout the software development process (e.g. user requirements specification, functional specification, design specification, code review, unit tests, integration tests, system tests).