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Validation and Qualification
Save Time and Effort on Full System Qualification
Qualify your instrument and monitor its operational condition for regulatory compliance efficiently and cost-effectively. Thermo Fisher Scientific’s system qualification packages provide the tools you need to complete this process quickly and give you documented evidence that your instrument will produce accurate results.
Achieve a fully qualified system with maximum accuracy and minimize the required time investment with a Thermo Fisher Scientific FT-IR, Raman, NIR, and UV-Vis instrument qualification package. Depending on the type of instrument, system qualification procedures are based on relevant industry-standard methods such as ASTM, ISO, as well as US, European, and Japanese Pharmacopeia. All qualification procedures use fully traceable reference materials so you can have confidence in the results.
Thermo Fisher Scientific’s unified qualification approach also covers specific accessories so that the entire system is qualified as a unit, rather than as separate components. In addition, factory certified test data can be provided for selected systems. And some systems also include software that can be used to periodically run the qualification tests and track results of system performance
- Detailed documentation binder (DQ/IQ/OQ/PQ) for neat and tidy qualification records
- Step-by-step IQ/OQ procedures, checklists, and signoff documents that are simple to execute
- Procedures follow industry-standard qualification methodologies so you can count on regulatory acceptance
- Traceable reference materials, available in formats for manual or automated testing, give you confidence in the test results
- Factory-certified performance test data (on selected instruments) provides factory traceability
- Software for performing and tracking qualification test results (on selected instruments) simplifies ongoing performance verification
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