{"id":24700,"date":"2025-03-06T08:09:36","date_gmt":"2025-03-06T08:09:36","guid":{"rendered":"https:\/\/sego3.pollen-partner.de\/process-validation\/"},"modified":"2025-11-13T11:30:59","modified_gmt":"2025-11-13T11:30:59","slug":"process-validation","status":"publish","type":"post","link":"https:\/\/sego3.pollen-partner.de\/en\/process-validation\/","title":{"rendered":"PROCESS VALIDATION"},"content":{"rendered":"\t\t
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A smart hygienic decision<\/h2>\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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PROCESS VALIDATION<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Process validation is an essential and critical element for the security and correct functioning of medical devices and laboratory trials.<\/p>

  • Process validation is explicitly required in QM systems (DIN EN ISO 9001, DIN EN ISO 13485, GMP, DIN EN ISO 15189),
    in the guidelines of the German Medical Association (RiliB\u00c4K) and in the German Medical Devices Operator Ordinance (MPBetreibV).

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  • It includes preparation of documentary confirmation that a process will always create a result or product which conforms to the set requirements.<\/li><\/ul>\t\t\t\t\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\t\t\t\t<\/span><\/span>
    Areas of process validation<\/span> <\/th>Includes the<\/span><\/th>
    <\/span>    		In a nutshell<\/th><\/tr>
    Design Qualification (DQ)<\/span><\/td> <\/td>dokumentierten Nachweis, dass das Produkt (Ger\u00e4t) entsprechend den geplanten Anforderungen \/ Spezifikationen f\u00fcr den beabsichtigten Verwendungszweck geeignet istDefiniert die Kriterien f\u00fcr eine Kaufentscheidung<\/td><\/tr>
    Installation Qualification (IQ)<\/span><\/td> documentary confirmation that the version of the product (device) specified in the job and installed corresponds to the intended use and manufacturer\u00e2\u20ac\u2122s specifications<\/td>

    Describes all the installation steps for installing the product (device) and commissioning it<\/p><\/td><\/tr>

    Functional qualification \/
    Operational Qualification (OQ))<\/td>    		documentary confirmation that the version of the product (device) installed functions in accordance with its specifications<\/td> Ensures the basic functioning of the product (device) under the conditions and the place it is installed and in the working environmentr<\/td><\/tr>
    Performance Qualification (PQ)<\/td>documentary confirmation that the product (device) functions in accordance with the regulations and in compliance with the requirements (specifications) when operated under real (routine) conditions <\/td>Confirms the reproducible and permanently positive performance of a product (device) in accordance with the specifications when used under normal circumstances<\/td><\/tr>
    Maintenance, servicing, repair
    qualification \/ Maintenance Qualification (MQ) <\/span><\/td>    		documentary confirmation of regular main-tenance. Description of all the necessary cleaning, maintenance and servicing measuresdocumentary confirmation of regular main-tenance. Description of all the necessary cleaning, maintenance and servicing measures<\/td>Beschreibt den Description of the necessary efforts for maintenance of the product (device)<\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    A smart hygienic decision PROCESS VALIDATION Process validation is an essential and critical element for the security and correct functioning of medical devices and laboratory trials. Process validation is explicitly required in QM systems (DIN EN ISO 9001, DIN EN ISO 13485, GMP, DIN EN ISO 15189),in the guidelines of the German Medical Association (RiliB\u00c4K) […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[94],"tags":[],"class_list":["post-24700","post","type-post","status-publish","format-standard","hentry","category-internal-information"],"_links":{"self":[{"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/posts\/24700","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/comments?post=24700"}],"version-history":[{"count":9,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/posts\/24700\/revisions"}],"predecessor-version":[{"id":24710,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/posts\/24700\/revisions\/24710"}],"wp:attachment":[{"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/media?parent=24700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/categories?post=24700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sego3.pollen-partner.de\/en\/wp-json\/wp\/v2\/tags?post=24700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}