{"id":1510,"date":"2026-07-17T17:44:06","date_gmt":"2026-07-17T09:44:06","guid":{"rendered":"..\/..\/..\/..\/index.html\/?page_id=1510"},"modified":"2026-07-24T14:13:46","modified_gmt":"2026-07-24T06:13:46","slug":"fat","status":"publish","type":"page","link":"..\/..\/..\/..\/index.html\/fat\/","title":{"rendered":"FAT"},"content":{"rendered":"\t\t
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Factory Acceptance Test (FAT) & Full Validation Documentation Service<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Many pharmaceutical firms require audit-compliant paperwork before equipment delivery to meet FDA 21 CFR Part 11, EU GMP, NMPA and GAMP5 standards; Shanghai Reliance Machinery offers on-site witnessed Factory Acceptance Test and complete validation document packages covering our filling, capping, Labelling, vision inspection and cartoning machinery, streamlining URS traceability and audit file preparation by conducting strict FAT testing against your User Requirement Specification, logging all test data and issuing signed official documents to help you pass international third-party audits efficiently, and we will tailor a dedicated FAT inspection plan and full validation document set once you provide your URS and project needs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Standard FAT Implementation Workflow<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Our standardized FAT procedure covers every stage from design confirmation to post-delivery technical support. You may choose to dispatch your engineers for on-site witnessing or adopt remote video inspection. All test records and validation files will be archived and provided as formal deliverables after acceptance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tURS & DQ Design Confirmation\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tCross-check your URS and complete Design Qualification review to lock all technical specifications prior to production.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\n\t\t\t\t\t\t\tIn-house Assembly & Pre-FAT Debugging\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tFinish full machine assembly, repeated operation testing and parameter calibration within our factory workshop.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\n\t\t\t\t\t\t\tOn-site Witnessed FAT Inspection\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tSupport your team to attend on-site FAT witnessing, run full function tests and verify machine performance on site.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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\n\t\t\t\t\t\t\tFAT Report & Original Data Archiving\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tCompile signed FAT acceptance report, save test videos, dimension records and raw testing data for permanent traceability.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\n\t\t\t\t\t\t\tAnti-dust Packing & Global Logistics Delivery\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t Carry out professional sealed packaging and arrange international shipment only after FAT approval is fully completed.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\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\n\t\t\t\t\t\t\tSAT Guidance & Extended Validation Service\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t Provide Site Acceptance Test guidance and optional IQ\/OQ\/FMEA supplementary documents after equipment arrives at your factory.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Select FAT & Validation Service for Your Equipment Type<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Fully customizing verification documents and FAT inspection plans from scratch will prolong your project audit cycle and delay equipment formal put-into-production.<\/div><\/div>
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Shanghai Reliance Machinery provides targeted FAT witness testing and matched validation document packages based on our mature standard filling, capping, Labelling, inspection and packaging equipment series, greatly shortening your project approval and delivery schedule.<\/div><\/div>
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Our mainstream pharmaceutical equipment supports exclusive FAT & validation customization, including aseptic filling production lines, monoblock integrated filling-capping units, rotary continuous filling equipment, automatic stoppering machines and multi-functional Labelling systems. Each set of service strictly complies with URS, GMP, FDA 21 CFR Part 11 and GAMP5 specifications, with complete test records and traceable audit files.<\/div><\/div>
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Below are our mainstream pharmaceutical production lines, with tailor-made FAT witness inspection and full validation document packages available to match each equipment model.<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t
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Automatic Eye Drops Filling & Capping Production Line<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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GMP-compliant integrated line for sterile eye drop filling and sealing, with customized FAT test items and traceable audit documentation available.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Full Automatic Nasal Spray Filling Crimping Production Line<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Auto filling and crimping equipment dedicated to nasal spray dosage forms, supporting FAT witnessing and compliance validation files as per your URS requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Pharmaceutical Oral Liquid Solution Filling Packaging Line<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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High-speed filling & packaging unit for pharmaceutical oral liquid products, complete with standard FAT test records and expandable optional validation documents.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Monoblock Integrated Automatic Filling And Capping Machine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Compact monoblock eye drop filling and capping unit, deliverable with signed FAT acceptance report and machine operation test footage.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Automatic Liquid Filling And Rubber Stoppering Machine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Precise dosing and rubber stoppering equipment for sterile vial production, with fully customizable FAT inspection workflow and audit file package.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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High Speed Rotary Continuous Filling Capping Machine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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High-speed rotary type filler & capper for continuous mass pharmaceutical production, eligible for on-site or remote online FAT witnessing service.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Included & Optional FAT Validation Documentation Items<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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If you need a clear scope of Factory Acceptance Test and validation documents before confirming your order, we provide fixed standard deliverables for all FAT services along with customizable optional validation files to satisfy various audit and compliance requirements; many overseas pharmaceutical project clients find it confusing to distinguish default included verification paperwork and extra attachable documents, and with extensive experience delivering FAT and validation services for pharmaceutical machinery, Shanghai Reliance Machinery offers fully transparent document scope to prevent omissions of audit materials, and you may check the complete list of standard deliverables and optional add-on items below, then send us your project demands so our engineering team can finalize the exact document package and specify all contents clearly in the formal contract.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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Standard features<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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