{"id":2364,"date":"2025-04-02T17:21:10","date_gmt":"2025-04-02T17:21:10","guid":{"rendered":"https:\/\/dev.elifesciences.co\/maintenance-of-the-validated-state\/"},"modified":"2025-05-08T11:55:59","modified_gmt":"2025-05-08T11:55:59","slug":"maintenance-of-the-validated-state","status":"publish","type":"page","link":"https:\/\/elifesciences.co\/en\/services\/maintenance-of-the-validated-state\/","title":{"rendered":"Maintenance of the validated state"},"content":{"rendered":"\t\t

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Maintenance of the validated state<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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How not to lose a validated system<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Maintenance of the validated state is no less important than the validation itself.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Upon completion of proper validation and the launch of production, the object of validation \/ qualification moves into the state of operation and maintenance.<\/p>\n<\/div>\n
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This means that from that moment one should take care that none of the activities performed should cause the loss of the validated state.<\/p>\n<\/div>\n
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tProperly implemented \u201cMaintenance of the validated state\u201d allows to save time and costs, when managing existing and validated system and\/or equipment.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Stability after validation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Validate is not enough the key is to maintain the state of validation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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The most common causes of the loss of the validated state are:<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tbreakdowns and repairs<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tchange implementation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tamendments to laws and standards<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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What is also connected with the\u00a0operation and maintenance state<\/strong>\u00a0is also withdrawal from use.<\/p>\n
The stage of withdrawal from use is also\u00a0incorporated into the validation life cycle and requires taking appropriate action.<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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The most frequent processes being part of the maintenance of the validated state include:<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tincident management<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tchange management<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tperiodic inspections (APR, regarding equipment, installations, etc.)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\trevalidation and re-qualification<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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We perform the following, among other things, as part of the maintenance of the validated state:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tProcedures and instructions\t\t\t\t\t<\/h5>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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We develop relevant procedures and instructions<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tTraining\t\t\t\t\t<\/h5>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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We conduct training and implementations as per the instructions mentioned above<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tIncident management and change control\t\t\t\t\t<\/h5>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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We take an active part in incident management and change control processes (we review and assess changes, supervise scheduled actions, perform validation activities \u2013 for example, preparation of documentation and testing)<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tReviews\t\t\t\t\t<\/h5>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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We perform periodic inspections<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\tRevalidation and requalification\t\t\t\t\t<\/h5>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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We do revalidation and re-qualification (to the extent identified in the risk assessment)<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t $\"\"$ \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Find out how our validation experts can support you<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tGet in touch<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"
How not to lose a validated system Maintenance of the validated state is no less important than the validation itself. Upon completion of proper validation and the launch of production, the object of validation \/ qualification moves into the state of operation and maintenance. This means that from that moment one should take care that […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":2356,"menu_order":46,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-2364","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2364","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/comments?post=2364"}],"version-history":[{"count":1,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2364\/revisions"}],"predecessor-version":[{"id":2365,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2364\/revisions\/2365"}],"up":[{"embeddable":true,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2356"}],"wp:attachment":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/media?parent=2364"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}