{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T12:46:14Z","timestamp":1782996374860,"version":"3.54.5"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,2]]},"DOI":"10.7759\/cureus.111945","type":"journal-article","created":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T12:01:35Z","timestamp":1782993695000},"source":"Crossref","is-referenced-by-count":0,"title":["Makeen Document Control System: Development, Standards-Based Validation, and Early Multisite Implementation of a Saudi-Built Laboratory Document Control Platform"],"prefix":"10.7759","author":[{"given":"Kaneez","family":"Zamir","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulaziz","family":"Johani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Qassas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulrahman","family":"Aboud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bilal","family":"Waheed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","reference":[{"key":"ref1","article-title":"Role of accreditation procedures in maintaining quality","author":"Bogusz MJ","year":"2011","unstructured":"Bogusz MJ, Hassan H. Role of accreditation procedures in maintaining quality. Quality Assurance in the Pathology Laboratory: Forensic, Technical, and Ethical Aspects. Bogusz MJ (ed): Taylor & Francis Group, Boca Raton, FL; 2011. 139-204."},{"key":"ref2","unstructured":"ISO 15189.2022(en) medical laboratories - requirements for quality and competence. (2022). Accessed: June 30, 2026: https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:15189:ed-4:v1:en."},{"key":"ref3","unstructured":"Standards for blood banks and transfusion services, 33rd edition - portal. (2022). Accessed. June 30, 2026: https:\/\/www.aabb.org\/aabb-store\/product\/standards-for-blood-banks-and-transfusion-services-33rd-edition---portal-1599...."},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2022-1229","article-title":"Crossing the chasm: strategies for digital transformation in clinical laboratories","volume":"61","author":"Gungoren MS","year":"2023","unstructured":"Gungoren MS. Crossing the chasm: strategies for digital transformation in clinical laboratories. Clin Chem Lab Med. 2023, 61:570-5. 10.1515\/cclm-2022-1229","journal-title":"Clin Chem Lab Med"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2024.1363957","article-title":"Benchmarking medical laboratory performance on a global scale","volume":"12","author":"Huf W","year":"2024","unstructured":"Huf W, Mohns M, Almeta E, et al.. Benchmarking medical laboratory performance on a global scale. Front Public Health. 2024, 12:1363957. 10.3389\/fpubh.2024.1363957","journal-title":"Front Public Health"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1088\/1757-899x\/1268\/1\/012001","article-title":"Digital transformation of the laboratories","author":"Comeaga M","year":"2022","unstructured":"Comeaga M. Digital transformation of the laboratories. 12th International Conference on Advanced Manufacturing Technologies (ICAMaT 2022). IOP Publishing, Bucharest, Romania; 2022. 1268:012001. 10.1088\/1757-899x\/1268\/1\/012001"},{"key":"ref7","unstructured":"Part 11, electronic records; electronic signatures - scope and application. (2003). Accessed. June 30, 2026: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signat...."},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1186\/s12875-021-01449-1","article-title":"Clinical laboratory services for primary healthcare centers in urban cities: a pilot ACO model of ten primary healthcare centers","volume":"22","author":"Tashkandi SA","year":"2021","unstructured":"Tashkandi SA, Alenezi A, Bakhsh I, et al.. Clinical laboratory services for primary healthcare centers in urban cities: a pilot ACO model of ten primary healthcare centers. BMC Fam Pract. 2021, 22:105. 10.1186\/s12875-021-01449-1","journal-title":"BMC Fam Pract"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.95137","article-title":"An overview of Central Board for the Accreditation of Healthcare Institutions in Saudi Arabia: a narrative review","volume":"17","author":"Alturbag M","year":"2025","unstructured":"Alturbag M, Alyahya A. An overview of Central Board for the Accreditation of Healthcare Institutions in Saudi Arabia: a narrative review. Cureus. 2025, 17:e95137. 10.7759\/cureus.95137","journal-title":"Cureus"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.4103\/jdmimsu.jdmimsu_128_22","article-title":"What has been the impact of laboratory accreditation in Saudi Arabia? A cross-sectional survey of laboratory practitioners","volume":"18","author":"Alsayyah A","year":"2023","unstructured":"Alsayyah A, Almulhim A. What has been the impact of laboratory accreditation in Saudi Arabia? A cross-sectional survey of laboratory practitioners. J Datta Meghe Inst Med Sci Univ. 2023, 18:398-404. 10.4103\/jdmimsu.jdmimsu_128_22","journal-title":"J Datta Meghe Inst Med Sci Univ"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare12020183","article-title":"Perceptions, attitudes, and barriers towards the use of Central Board for Accreditation of Healthcare Institutions (CBAHI) standards among Saudi healthcare providers","volume":"12","author":"Kabrah SM","year":"2024","unstructured":"Kabrah SM, Abuzerr S, Flemban A, et al.. Perceptions, attitudes, and barriers towards the use of Central Board for Accreditation of Healthcare Institutions (CBAHI) standards among Saudi healthcare providers. Healthcare (Basel). 2024, 12:183. 10.3390\/healthcare12020183","journal-title":"Healthcare (Basel)"},{"key":"ref12","unstructured":"Personal data protection law. (2024). Accessed. June 30, 2026: https:\/\/sdaia.gov.sa\/en\/SDAIA\/about\/Documents\/Personal%20Data%20English%20V2-23April2023-%20Reviewed-.pdf."},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.47278\/journal.ijab\/2024.091","article-title":"Overview of quality control and safety in public health pest laboratory in Jeddah, Saudi Arabia","volume":"13","author":"Elkhalifa SM","year":"2024","unstructured":"Elkhalifa SM, Altilmisani NM, Albishri F, Gad HA, Al-Dubai TA, Al-Wesabi EO. Overview of quality control and safety in public health pest laboratory in Jeddah, Saudi Arabia. Int J Agric Biosci. 2024, 13:92-100. 10.47278\/journal.ijab\/2024.091","journal-title":"Int J Agric Biosci"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.3389\/fbioe.2025.1578654","article-title":"Laboratory quality management system fundamentals","volume":"13","author":"Pillai SP","year":"2025","unstructured":"Pillai SP, Fox E. Laboratory quality management system fundamentals. Front Bioeng Biotechnol. 2025, 13:1578654. 10.3389\/fbioe.2025.1578654","journal-title":"Front Bioeng Biotechnol"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.3389\/fbioe.2022.1040103","article-title":"Practical considerations for laboratories: implementing a holistic quality management system","volume":"10","author":"Pillai S","year":"2022","unstructured":"Pillai S, Calvert J, Fox E. Practical considerations for laboratories: implementing a holistic quality management system. Front Bioeng Biotechnol. 2022, 10:1040103. 10.3389\/fbioe.2022.1040103","journal-title":"Front Bioeng Biotechnol"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2017.37.5.365","article-title":"International Organization for Standardization (ISO) 15189","volume":"37","author":"Schneider F","year":"2017","unstructured":"Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017, 37:365-70. 10.3343\/alm.2017.37.5.365","journal-title":"Ann Lab Med"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.37432\/jieph-d-25-00011","article-title":"Implementation of laboratory quality management system: a cornerstone for enhanced patient safety and clinical outcomes in Tanzania","volume":"8","author":"Shedura VJ","year":"2025","unstructured":"Shedura VJ, Malindisa KK, Nanyanga SJ. Implementation of laboratory quality management system: a cornerstone for enhanced patient safety and clinical outcomes in Tanzania. J Interv Epidemiol Public Health. 2025, 8:84. 10.37432\/jieph-d-25-00011","journal-title":"J Interv Epidemiol Public Health"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.30574\/wjarr.2025.26.2.2045","article-title":"The critical role of laboratory informatics systems in ensuring public safety in pharmaceutical development","volume":"26","author":"Kannan V","year":"2025","unstructured":"Kannan V. The critical role of laboratory informatics systems in ensuring public safety in pharmaceutical development. World J Adv Res Rev. 2025, 26:3620-8. 10.30574\/wjarr.2025.26.2.2045","journal-title":"World J Adv Res Rev"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1016\/j.labinv.2023.100246","article-title":"Quality management system in clinical digital pathology operations at a tertiary cancer center","volume":"103","author":"Ardon O","year":"2023","unstructured":"Ardon O, Labasin M, Friedlander M, et al.. Quality management system in clinical digital pathology operations at a tertiary cancer center. Lab Invest. 2023, 103:100246. 10.1016\/j.labinv.2023.100246","journal-title":"Lab Invest"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1007\/10_2021_190","article-title":"Flexible digitization of highly individualized workflows demonstrated through the quality control of patient-specific cytostatic application bags: digitization from the perspective of small and medium-sized laboratories","author":"Jochums M","year":"2022","unstructured":"Jochums M, Reinders LM, Tuerk J, Teutenberg T. Flexible digitization of highly individualized workflows demonstrated through the quality control of patient-specific cytostatic application bags: digitization from the perspective of small and medium-sized laboratories. Smart Biolabs of the Future. Beutel S, Lenk F (ed): Springer, Cham, Switzerland; 2022. 182:115-29. 10.1007\/10_2021_190"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiochem.2025.110915","article-title":"Establishing sustainable quality improvement in the clinical laboratory: redesign of the total testing process and digital transformation of routine quality assurance activities","volume":"137","author":"Fung AW","year":"2025","unstructured":"Fung AW. Establishing sustainable quality improvement in the clinical laboratory: redesign of the total testing process and digital transformation of routine quality assurance activities. Clin Biochem. 2025, 137:110915. 10.1016\/j.clinbiochem.2025.110915","journal-title":"Clin Biochem"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.26719\/2002.8.4-5.654","article-title":"Overview of the laboratory accreditation programme of the College of American Pathologists","volume":"8","author":"Abu-Amero KK","year":"2002","unstructured":"Abu-Amero KK. Overview of the laboratory accreditation programme of the College of American Pathologists. East Mediterr Health J. 2002, 8:654-63. 10.26719\/2002.8.4-5.654","journal-title":"East Mediterr Health J"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-025-30089-z","article-title":"Impact of SAAC accreditation on laboratories in Saudi Arabia according to ISO\/IEC 17025:2017","volume":"16","author":"Alomair A","year":"2026","unstructured":"Alomair A, Alfayez M, Abuhaimed M, Alrabeh M. Impact of SAAC accreditation on laboratories in Saudi Arabia according to ISO\/IEC 17025:2017. Sci Rep. 2026, 16:589. 10.1038\/s41598-025-30089-z","journal-title":"Sci Rep"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.2196\/36778","article-title":"The need for standards unification in forensic laboratory practices: protocol for setting up the Arab Forensic Laboratories Accreditation Center","volume":"11","author":"AlMazroua MK","year":"2022","unstructured":"AlMazroua MK, Mahmoud NF. The need for standards unification in forensic laboratory practices: protocol for setting up the Arab Forensic Laboratories Accreditation Center. JMIR Res Protoc. 2022, 11:e36778. 10.2196\/36778","journal-title":"JMIR Res Protoc"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.2196\/19338","article-title":"Digital response during the COVID-19 pandemic in Saudi Arabia","volume":"22","author":"Hassounah M","year":"2020","unstructured":"Hassounah M, Raheel H, Alhefzi M. Digital response during the COVID-19 pandemic in Saudi Arabia. J Med Internet Res. 2020, 22:e19338. 10.2196\/19338","journal-title":"J Med Internet Res"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.9734\/ajrcos\/2025\/v18i10768","article-title":"Data sovereignty and digital health transformation in Saudi Arabia: a review with policy implications for Vision 2030","volume":"18","author":"Albaroudi E","year":"2025","unstructured":"Albaroudi E, Elbehairy M, Hinnawi M, Hatamleh M, Mansouri T, Alameer A. Data sovereignty and digital health transformation in Saudi Arabia: a review with policy implications for Vision 2030. Asian J Res Comput Sci. 2025, 18:115-35. 10.9734\/ajrcos\/2025\/v18i10768","journal-title":"Asian J Res Comput Sci"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.69554\/elux6976","article-title":"Evaluating the effectiveness of Saudi Arabia\u2019s PDPL in the global digital economy","volume":"8","author":"Suliman H","year":"2025","unstructured":"Suliman H. Evaluating the effectiveness of Saudi Arabia\u2019s PDPL in the global digital economy. J Data Prot Priv. 2025, 8:97-111. 10.69554\/elux6976","journal-title":"J Data Prot Priv"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.18421\/tem112-21","article-title":"Developing a quality automation framework to assess specifications for academic accreditation in Saudi Arabian universities","volume":"11","author":"Aljarallah NA","year":"2022","unstructured":"Aljarallah NA, Dutta AK. Developing a quality automation framework to assess specifications for academic accreditation in Saudi Arabian universities. TEM J. 2022, 11:667-74. 10.18421\/tem112-21","journal-title":"TEM J"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.7717\/peerj-cs.1120","article-title":"Developing a blockchain-based digitally secured model for the educational sector in Saudi Arabia toward digital transformation","volume":"8","author":"Alangari S","year":"2022","unstructured":"Alangari S, Alshahrani SM, Khan NA, Alghamdi AA, Almalki J, Al Shehri W. Developing a blockchain-based digitally secured model for the educational sector in Saudi Arabia toward digital transformation. PeerJ Comput Sci. 2022, 8:e1120. 10.7717\/peerj-cs.1120","journal-title":"PeerJ Comput Sci"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1128\/9781555817282.ch22","article-title":"International Organization for Standardization","author":"Marsden A","year":"2013","unstructured":"Marsden A, Shahtout A. International Organization for Standardization. Clinical Laboratory Management, Second Edition. Garcia LS, Bachner P, Baselski VS, et al. (ed): ASM Press, Washington, DC; 2013. 447-50. 10.1128\/9781555817282.ch22"}],"container-title":["Cureus"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cureus.com\/articles\/486596-makeen-document-control-system-development-standards-based-validation-and-early-multisite-implementation-of-a-saudi-built-laboratory-document-control-platform","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T12:01:44Z","timestamp":1782993704000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cureus.com\/articles\/486596-makeen-document-control-system-development-standards-based-validation-and-early-multisite-implementation-of-a-saudi-built-laboratory-document-control-platform"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,2]]},"references-count":30,"URL":"https:\/\/doi.org\/10.7759\/cureus.111945","relation":{},"ISSN":["2168-8184"],"issn-type":[{"value":"2168-8184","type":"print"}],"subject":[],"published":{"date-parts":[[2026,7,2]]}}}