Factory Acceptance Test (FAT) & Full Validation Documentation Service
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.
Standard FAT Implementation Workflow
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.
URS & DQ Design Confirmation
Cross-check your URS and complete Design Qualification review to lock all technical specifications prior to production.
In-house Assembly & Pre-FAT Debugging
Finish full machine assembly, repeated operation testing and parameter calibration within our factory workshop.
On-site Witnessed FAT Inspection
Support your team to attend on-site FAT witnessing, run full function tests and verify machine performance on site.
FAT Report & Original Data Archiving
Compile signed FAT acceptance report, save test videos, dimension records and raw testing data for permanent traceability.
Anti-dust Packing & Global Logistics Delivery
Carry out professional sealed packaging and arrange international shipment only after FAT approval is fully completed.
SAT Guidance & Extended Validation Service
Provide Site Acceptance Test guidance and optional IQ/OQ/FMEA supplementary documents after equipment arrives at your factory.
Select FAT & Validation Service for Your Equipment Type
Automatic Eye Drops Filling & Capping Production Line
GMP-compliant integrated line for sterile eye drop filling and sealing, with customized FAT test items and traceable audit documentation available.
Full Automatic Nasal Spray Filling Crimping Production Line
Auto filling and crimping equipment dedicated to nasal spray dosage forms, supporting FAT witnessing and compliance validation files as per your URS requirements.
Pharmaceutical Oral Liquid Solution Filling Packaging Line
High-speed filling & packaging unit for pharmaceutical oral liquid products, complete with standard FAT test records and expandable optional validation documents.
Monoblock Integrated Automatic Filling And Capping Machine
Compact monoblock eye drop filling and capping unit, deliverable with signed FAT acceptance report and machine operation test footage.
Automatic Liquid Filling And Rubber Stoppering Machine
Precise dosing and rubber stoppering equipment for sterile vial production, with fully customizable FAT inspection workflow and audit file package.
High Speed Rotary Continuous Filling Capping Machine
High-speed rotary type filler & capper for continuous mass pharmaceutical production, eligible for on-site or remote online FAT witnessing service.
Included & Optional FAT Validation Documentation Items
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.
Standard features
- Signed Official FAT Factory Acceptance Test Report
- Complete machine running test videos & original test data logs
- Basic DQ Design Qualification documents & drawing archives
- Full BOM component list, material certification & dimension records
- Standard SAT Site Acceptance Test template document set
Optional features
- Complete IQ Installation Qualification & OQ Operational Qualification files
- FMEA risk analysis, deviation record and change control documents
- Editable electronic files fully compliant with 21 CFR Part 11
- Third-party audit assistance & document revision service
- Remote online FAT witnessing without client on-site visit
Custom FAT Witness Modes & Project Tailoring Support
We offer two flexible FAT witnessing modes to accommodate your project schedule and travel arrangements: on-site factory inspection with your assigned engineers, and online remote video witnessing with real-time live streaming of all test procedures.
For special pharmaceutical projects with unique URS clauses or extra regulatory audit demands, our engineering team will revise the entire FAT checklist, test items and validation document structure separately instead of applying the fixed standard package, to fully align with your local drug administration and third-party audit requirements.
All customized FAT schemes will be confirmed in writing and appended to the formal sales contract to eliminate ambiguity during equipment acceptance.
FAT Witness & On-site Testing Video Cases
On-site FAT Witness Inspection Recording
Remote Online FAT Live Verification
Let’s work together
We welcome your enquiries regarding FAT acceptance testing and pharmaceutical equipment validation services. You may submit your demands via the contact form below or reach out to us directly by email.
