{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T17:08:26Z","timestamp":1783616906985,"version":"3.55.0"},"publisher-location":"Cham","reference-count":19,"publisher":"Springer International Publishing","isbn-type":[{"value":"9783030588571","type":"print"},{"value":"9783030588588","type":"electronic"}],"license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,9,24]],"date-time":"2020-09-24T00:00:00Z","timestamp":1600905600000},"content-version":"vor","delay-in-days":267,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>For established domains within highly regulated environments, a systematic approach is needed to scale agile methods and assure compliance with regulatory requirements. The presented approach works adequately in small agile teams \u2013 independently of the underlying method such as Scrum, Kanban, etc. \u2013 and is scalable to more and bigger teams or even entire subsidiaries. It is based on a compliance and a quality risk dimension respectively. Both dimensions are needed to fit regulatory requirements in our finance example with more than 100 developers in one subsidiary.<\/jats:p>","DOI":"10.1007\/978-3-030-58858-8_12","type":"book-chapter","created":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T18:02:34Z","timestamp":1600884154000},"page":"111-119","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["A Systematic Approach to Agile Development in Highly Regulated Environments"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2868-5633","authenticated-orcid":false,"given":"Alexander","family":"Poth","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Jacobsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Riel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,9,24]]},"reference":[{"key":"12_CR1","unstructured":"General Data Protection Regulation (GDPR). https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32016R0679 . Accessed 11 June 2020"},{"key":"12_CR2","unstructured":"Handelsgesetzbuch (HGB). http:\/\/www.gesetze-im-internet.de\/englisch_hgb\/ . Accessed 11 June 2020"},{"key":"12_CR3","unstructured":"Mindestanforderungen an das Risikomanagement (MARisk). https:\/\/www.bafin.de\/SharedDocs\/Veroeffentlichugen\/DE\/Rundschreiben\/2017\/rs_1709_marisk_ba.html . Accessed 11 June 2020"},{"key":"12_CR4","doi-asserted-by":"crossref","unstructured":"Fitzgerald, B., Stol, K.-J., O\u2019Sullivan, R., O\u2019Brien, D.: Scaling agile methods to regulated environments: an industry case study. In: 35th International Conference on Software Engineering (ICSE), pp. 863\u2013872. IEEE (2013)","DOI":"10.1109\/ICSE.2013.6606635"},{"key":"12_CR5","series-title":"Lecture Notes in Business Information Processing","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1007\/978-3-319-91602-6_9","volume-title":"Agile Processes in Software Engineering and Extreme Programming","author":"T Karvonen","year":"2018","unstructured":"Karvonen, T., Sharp, H., Barroca, L.: Enterprise agility: why is transformation so hard? In: Garbajosa, J., Wang, X., Aguiar, A. (eds.) XP 2018. LNBIP, vol. 314, pp. 131\u2013145. Springer, Cham (2018). https:\/\/doi.org\/10.1007\/978-3-319-91602-6_9"},{"key":"12_CR6","doi-asserted-by":"crossref","unstructured":"Uludag, O., Kleehaus, M., Caprano, C., Matthes, F.: Identifying and structuring challenges in large-scale agile development based on a structured literature review. In: 2018 IEEE 22nd International Enterprise Distributed Object Computing Conference (EDOC), pp. 191\u2013197. IEEE (2018)","DOI":"10.1109\/EDOC.2018.00032"},{"key":"12_CR7","doi-asserted-by":"publisher","first-page":"194","DOI":"10.1016\/j.infsof.2015.12.003","volume":"74","author":"VP Eloranta","year":"2016","unstructured":"Eloranta, V.P., Koskimies, K., Mikkonen, T.: Exploring ScrumBut\u2014an empirical study of scrum anti-patterns. Inf. Softw. Technol. 74, 194\u2013203 (2016)","journal-title":"Inf. Softw. Technol."},{"key":"12_CR8","doi-asserted-by":"publisher","unstructured":"Wolff, S.: Scrum goes formal: agile methods for safety-critical systems. In: 2012 First International Workshop on Formal Methods in Software Engineering: Rigorous and Agile Approaches (FormSERA), Zurich, pp. 23\u201329 (2012). https:\/\/doi.org\/10.1109\/formsera.2012.6229784","DOI":"10.1109\/formsera.2012.6229784"},{"key":"12_CR9","doi-asserted-by":"crossref","unstructured":"Mc Hugh, M., Cawley, O., McCaffcry, F., Richardson, I., Wang, X.: An agile v-model for medical device software development to over-come the challenges with plan-driven software development lifecycles. In: 5th International Workshop on Software Engineering in Health Care (SEHC), pp. 12\u201319. IEEE (2013)","DOI":"10.1109\/SEHC.2013.6602471"},{"issue":"2","key":"12_CR10","first-page":"39","volume":"59","author":"J Birkinshaw","year":"2018","unstructured":"Birkinshaw, J.: What to expect from agile. MIT Sloan Manag. Rev. 59(2), 39\u201342 (2018)","journal-title":"MIT Sloan Manag. Rev."},{"key":"12_CR11","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1007\/978-1-4419-5653-8_2","volume-title":"Design Research in Information Systems","author":"A Hevner","year":"2010","unstructured":"Hevner, A., Samir, C.: Design science research in information systems. Design Research in Information Systems, pp. 9\u201322. Springer, Boston (2010). https:\/\/doi.org\/10.1007\/978-1-4419-5653-8_2"},{"issue":"6","key":"12_CR12","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1109\/MS.2013.138","volume":"31","author":"A Poth","year":"2014","unstructured":"Poth, A., Sunyaev, A.: Effective quality management: risk- and value-based software quality management. IEEE Softw. 31(6), 79\u201385 (2014)","journal-title":"IEEE Softw."},{"key":"12_CR13","doi-asserted-by":"publisher","unstructured":"Perkusich, M., et al.: A systematic review on the use of Definition of Done on agile software development projects. In: International Conference on Evaluation and Assessment in Software Engineering (EASE) (2017). https:\/\/doi.org\/10.1145\/3084226.3084262","DOI":"10.1145\/3084226.3084262"},{"key":"12_CR14","series-title":"Lecture Notes in Business Information Processing","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1007\/978-3-319-06862-6_25","volume-title":"Agile Processes in Software Engineering and Extreme Programming","author":"K Power","year":"2014","unstructured":"Power, K.: Definition of ready: an experience report from teams at Cisco. In: Cantone, G., Marchesi, M. (eds.) XP 2014. LNBIP, vol. 179, pp. 312\u2013319. Springer, Cham (2014). https:\/\/doi.org\/10.1007\/978-3-319-06862-6_25"},{"issue":"11","key":"12_CR15","doi-asserted-by":"publisher","first-page":"1000","DOI":"10.1002\/smr.1823","volume":"28","author":"A Poth","year":"2016","unstructured":"Poth, A.: Effectivity and economical aspects for agile quality assurance in large enterprises. J. Softw. Process: Improv. Pract. 28(11), 1000\u20131004 (2016)","journal-title":"J. Softw. Process: Improv. Pract."},{"issue":"5","key":"12_CR16","first-page":"28","volume":"14","author":"ME Conway","year":"1968","unstructured":"Conway, M.E.: How do committees invent? Datamation 14(5), 28\u201331 (1968)","journal-title":"Datamation"},{"key":"12_CR17","doi-asserted-by":"crossref","unstructured":"Poth, A., Riel, A.: Quality requirements elicitation by ideation of product quality risks with design thinking. In: Proceedings of the 28th IEEE International Requirements Engineering Conference (RE 2020), Vienna (2020, in print)","DOI":"10.1109\/RE48521.2020.00034"},{"key":"12_CR18","unstructured":"BAIT. https:\/\/www.bafin.de\/SharedDocs\/Downloads\/EN\/Rundschreiben\/dl_rs_1710_ba_BAIT_en.pdf?__blob=publicationFile&v=6 . Accessed 11 June 2020"},{"key":"12_CR19","unstructured":"INVEST. https:\/\/xp123.com\/articles\/invest-in-good-stories-and-smart-tasks\/ . Accessed 11 June 2020"}],"container-title":["Lecture Notes in Business Information Processing","Agile Processes in Software Engineering and Extreme Programming \u2013 Workshops"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-030-58858-8_12","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,3]],"date-time":"2021-04-03T18:50:58Z","timestamp":1617475858000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-030-58858-8_12"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020]]},"ISBN":["9783030588571","9783030588588"],"references-count":19,"URL":"https:\/\/doi.org\/10.1007\/978-3-030-58858-8_12","relation":{},"ISSN":["1865-1348","1865-1356"],"issn-type":[{"value":"1865-1348","type":"print"},{"value":"1865-1356","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020]]},"assertion":[{"value":"24 September 2020","order":1,"name":"first_online","label":"First Online","group":{"name":"ChapterHistory","label":"Chapter History"}},{"value":"XP","order":1,"name":"conference_acronym","label":"Conference Acronym","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"International Conference on Agile Software Development","order":2,"name":"conference_name","label":"Conference Name","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"Copenhagen","order":3,"name":"conference_city","label":"Conference City","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"Denmark","order":4,"name":"conference_country","label":"Conference Country","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"2020","order":5,"name":"conference_year","label":"Conference Year","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"8 June 2020","order":7,"name":"conference_start_date","label":"Conference Start Date","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"12 June 2020","order":8,"name":"conference_end_date","label":"Conference End Date","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"21","order":9,"name":"conference_number","label":"Conference Number","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"xpu2020","order":10,"name":"conference_id","label":"Conference ID","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"https:\/\/www.agilealliance.org\/xp2020\/","order":11,"name":"conference_url","label":"Conference URL","group":{"name":"ConferenceInfo","label":"Conference Information"}},{"value":"Single-blind","order":1,"name":"type","label":"Type","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"EasyChair","order":2,"name":"conference_management_system","label":"Conference Management System","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"79","order":3,"name":"number_of_submissions_sent_for_review","label":"Number of Submissions Sent for Review","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"14","order":4,"name":"number_of_full_papers_accepted","label":"Number of Full Papers Accepted","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"2","order":5,"name":"number_of_short_papers_accepted","label":"Number of Short Papers Accepted","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"18% - The value is computed by the equation \"Number of Full Papers Accepted \/ Number of Submissions Sent for Review * 100\" and then rounded to a whole number.","order":6,"name":"acceptance_rate_of_full_papers","label":"Acceptance Rate of Full Papers","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"3","order":7,"name":"average_number_of_reviews_per_paper","label":"Average Number of Reviews per Paper","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"3,2","order":8,"name":"average_number_of_papers_per_reviewer","label":"Average Number of Papers per Reviewer","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"Yes","order":9,"name":"external_reviewers_involved","label":"External Reviewers Involved","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}},{"value":"The conference was held online due to the Coronavirus pandemic. In addition to the main conference papers, 26 revised workshop papers, 2 Agile Education and Training Track papers, and 3 Doctoral Symposium papers were published.","order":10,"name":"additional_info_on_review_process","label":"Additional Info on Review Process","group":{"name":"ConfEventPeerReviewInformation","label":"Peer Review Information (provided by the conference organizers)"}}]}}