{"id":2379,"date":"2025-04-02T17:23:33","date_gmt":"2025-04-02T17:23:33","guid":{"rendered":"https:\/\/dev.elifesciences.co\/qualification-of-laboratory-and-production-equipment\/"},"modified":"2025-05-08T14:36:18","modified_gmt":"2025-05-08T14:36:18","slug":"qualification-of-laboratory-and-production-equipment","status":"publish","type":"page","link":"https:\/\/elifesciences.co\/en\/qualification-of-laboratory-and-production-equipment\/","title":{"rendered":"Qualification of Laboratory and Production Equipment"},"content":{"rendered":"\t\t

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Qualification of Laboratory and Production Equipment<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Qualification of Laboratory and Production Equipment<\/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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Qualification of devices in accordance with GMP and GAMP 5<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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At eLife Sciences, we specialize in the comprehensive qualification of both laboratory and production equipment, tailored to the requirements of regulated industries such as pharmaceuticals, biotechnology, and the medical sector. Our services ensure full compliance with applicable standards (GMP, GAMP 5, ISO) and prepare your equipment for safe and efficient operation.<\/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\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
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Our Approach to Equipment Qualification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The qualification process covers the full cycle, from planning and testing to complete documentation. We always adapt the scope of services to the specific equipment and the environment in which it will be used.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Our services include:<\/h3>\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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Installation Qualification (IQ)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Verification that the equipment has been installed correctly according to design specifications and manufacturer recommendations.<\/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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Operational Qualification (OQ)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Confirmation that the equipment operates according to defined operational parameters.<\/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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Performance Qualification (PQ)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Confirmation that the equipment performs effectively under real operating conditions.<\/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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Design Qualification (DQ)<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Ensuring that the equipment design meets quality and regulatory requirements.<\/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\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\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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Qualification of Laboratory Equipment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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In research and quality control laboratories, the reliability of equipment is crucial to ensure credible results. We offer the qualification of, among others:<\/p>\n\t\t\t\t\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\tspectrophotometers,<\/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\tchromatographs (HPLC, GC),<\/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\tanalytical balances,<\/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\tincubators and autoclaves,<\/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\tsample preparation and physicochemical analysis devices.<\/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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Our services also include support in developing validation strategies for new technologies and adapting existing procedures to electronic quality management systems.<\/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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Qualification of Production Equipment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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In pharmaceutical and biotechnological production environments, proper equipment qualification directly impacts the quality and safety of the final product. We conduct the qualification of, among others:<\/p>\n\t\t\t\t\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\treactors and bioreactors,<\/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\tfilling lines,<\/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\tHVAC and compressed air systems,<\/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\twater treatment systems (PW, WFI),<\/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\tpackaging and labeling 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
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We also address specific requirements for calibration, utilities qualification, and integration with environmental monitoring systems.<\/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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Why Choose Us for Equipment Qualification?<\/h2>\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\n\t\t\t\t\t\t\tExperience in both local and international projects.<\/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
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tA team of CSV and CQV experts with deep industry knowledge.<\/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
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tReady-to-use qualification documentation templates compliant with GAMP 5 guidelines.<\/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
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tFlexible approach tailored to the size and profile of your organization.<\/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
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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\tCapability to deliver fully paperless qualification processes.<\/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<\/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\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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Do you need a consultation? Contact us.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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We will be happy to review the details of your project and help you choose the most optimal solutions.<\/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\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":"
Qualification of Laboratory and Production Equipment Qualification of devices in accordance with GMP and GAMP 5 At eLife Sciences, we specialize in the comprehensive qualification of both laboratory and production equipment, tailored to the requirements of regulated industries such as pharmaceuticals, biotechnology, and the medical sector. Our services ensure full compliance with applicable standards (GMP, […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":48,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-2379","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2379","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=2379"}],"version-history":[{"count":1,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2379\/revisions"}],"predecessor-version":[{"id":2380,"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/pages\/2379\/revisions\/2380"}],"wp:attachment":[{"href":"https:\/\/elifesciences.co\/en\/wp-json\/wp\/v2\/media?parent=2379"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}