{"id":1778,"date":"2025-11-22T05:53:08","date_gmt":"2025-11-22T05:53:08","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=1778"},"modified":"2025-12-12T18:10:20","modified_gmt":"2025-12-12T18:10:20","slug":"alcoa","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=1778","title":{"rendered":"ALCOA ++"},"content":{"rendered":"

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Data Integrity: ALCOA ++<\/u><\/strong><\/h2>\n

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Regulatory Definitions of Data Integrity<\/strong><\/p>\n

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USFDA<\/strong>: \u201cData integrity refers to the completeness, consistency, and accuracy of data.\u00a0 Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded original, and accurate (ALCOA)\u201d.<\/p>\n

MHRA<\/strong>: \u201cThe extent to which all data are complete, consistent, and accurate throughout the data lifecycle.\u201d<\/p>\n

WHO<\/strong>: \u201cData integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate\u201d.<\/p>\n

PICS<\/strong>: \u201cData Integrity is defined as the extent to which all data are complete, consistent, and accurate, throughout the data lifecycle\u201d.<\/p>\n<\/div>\n<\/div>\n\n\n\n\n\n\n\n\n\n\n\n
Attributable<\/strong><\/td>\nThe Identity of the person completing a record (Who, When, <\/strong>Why).<\/strong><\/td>\n<\/tr>\n
Legible<\/strong><\/td>\nThe data is readable, Understandable, Traceable, Permanent <\/strong>allowing for a clear picture of the activities that occurred.<\/strong><\/td>\n<\/tr>\n
Contemporaneous<\/strong><\/td>\nThe data is recorded at the time it is generated or observed (No <\/strong>Back dating).<\/strong><\/td>\n<\/tr>\n
Original<\/strong><\/td>\nOriginal Records must preserve data accuracy, completeness, content and meaning. Data as the file or format in which it was <\/strong>initially generated.<\/strong><\/td>\n<\/tr>\n
Accurate<\/strong><\/td>\nThe data record must be accurate whether paper or electronic, <\/strong>it must be exact, true and free from error (this might require a second verification if necessary).<\/strong><\/td>\n<\/tr>\n
Consistent<\/strong><\/td>\nConsistent application of date and time stamps in the expected <\/strong>sequence.<\/strong><\/td>\n<\/tr>\n
Complete<\/strong><\/td>\nAll Information needs\u00a0 to be\u00a0 maintained. Batch pass-fail, <\/strong>Reanalyses carried out. (OOS, OOT).<\/strong><\/td>\n<\/tr>\n
Enduring<\/strong><\/td>\nMedium used to record data should be permanent and not <\/strong>temporary memory RAM.<\/strong><\/td>\n<\/tr>\n
Available<\/strong><\/td>\nAvailable\/Accessible for review \/ audit for the life time of the <\/strong>record.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a0 Data Integrity: ALCOA ++ \u00a0 Regulatory Definitions of Data Integrity USFDA: \u201cData integrity refers to the completeness, consistency, and accuracy of data.\u00a0 Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded original, and accurate (ALCOA)\u201d. MHRA: \u201cThe extent to which all data are complete, consistent, and accurate throughout the data lifecycle.\u201d WHO: […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[48,47],"class_list":["post-1778","post","type-post","status-publish","format-standard","hentry","category-pharma-definition-abbreviation","tag-qms","tag-quality-improvement"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1778","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1778"}],"version-history":[{"count":3,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1778\/revisions"}],"predecessor-version":[{"id":1831,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1778\/revisions\/1831"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}