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==Document control== [[Regulatory economics|Government regulations]] typically require that companies working in certain industries control their documents. A [[Document Controller]] is responsible to control these documents strictly. These industries include accounting (for example: 8th [[Directive (European Union)|EU Directive]], [[Sarbanes–Oxley Act]]), food safety (for example the [[Food Safety Modernization Act]] in the US), ISO (mentioned above), medical device manufacturing ([[Food and Drug Administration|FDA]]), manufacture of blood, human cells, and tissue products (FDA), healthcare (''[[JCAHO]]''), and information technology (''[[ITIL]]'').<ref> {{cite web |title = Code of Federal Regulations Title 21, Part 1271 |url = http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1 |publisher = Food and Drug Administration |access-date = 31 January 2012 |url-status = dead |archive-url = https://web.archive.org/web/20111010114628/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1 |archive-date = 10 October 2011 }} </ref> Some industries work under stricter document control requirements due to the type of information they retain for privacy, warranty, or other highly regulated purposes. Examples include [[protected health information]] (PHI) as required by [[HIPAA]] or construction project documents required for warranty periods. An information systems strategy plan (ISSP) can shape organisational information systems over medium to long-term periods.<ref> {{cite book |last1 = Wiggins |first1 = Bob |title = Effective Document Management: Unlocking Corporate Knowledge |year = 2000 |url = https://books.google.com/books?id=JnDwAAAAMAAJ |edition = 2 |publisher = Gower |publication-date = 2000 |page = 25 |isbn = 9780566081484 |access-date = 2016-04-09 |quote = At the organisational level an information systems strategy plan (ISSP) is a way to determine in general terms what information systems an organisation should have in place over the medium to long term (typically around three to five years [...]). |url-status = live |archive-url = https://web.archive.org/web/20180113184109/https://books.google.com/books?id=JnDwAAAAMAAJ |archive-date = 13 January 2018 }} </ref> Documents stored in a document management system—such as procedures, work instructions, and policy statements—provide evidence of documents under control. Failing to comply can cause fines, the loss of business, or damage to a business's reputation. Document control includes:<ref>{{cite web|url=https://www.isotracker.com/blog/what-is-document-control/|title=What is Document Control?|accessdate=9 November 2023|website=isoTracker}}</ref> * reviewing and approving documents prior to release * ensuring changes and revisions are clearly identified * ensuring that relevant versions of applicable documents are available at their "points of use" * ensuring that documents remain legible and identifiable * ensuring that external documents (such as customer-supplied documents or supplier manuals) are identified and controlled * preventing “unintended” use of obsolete documents These document control requirements form part of an organisation's [[compliance cost]]s alongside related functions such as a [[data protection officer]] and [[internal audit]].
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