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Qualification
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Phase
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Responsibility
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Activities
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Metrohm contribution
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SQ
Specification Qualification
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Instrument development
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Manufacturer
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Instrument hardware and software are developed and tested
according to defined guidelines.
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Metrohm AG is certified according to the ISO 9001
quality management system. Instrument development is
carried out in fixed steps and comprehensively documented.
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CQ
Construction Qualification
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Instrument manufacture and testing
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Manufacturer
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The instrument is produced and tested according to defined
quality guidelines.
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During manufacture and testing of the instrument the
requirements of the quality management system are strictly
adhered to.
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DQ
Design Qualification
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Instrument evaluation
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User
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Evidence that the instrument satisfies the set requirements.
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Technical advice provided by Metrohm.
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IQ
Installation Qualification
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Instrument installation
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User
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Checking and documenting that the instrument has been
correctly installed. Functional check.
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- Detaild instructions for use.
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Technical advice provided
on request.
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Logbook for Metrohm instruments.
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OQ
Operational Qualification
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Start-up
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User
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- Checking the specifications.
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Performance check, e.g.
titre determination.
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Application Bulletins with examples of Standard Operating
Procedures for performance checks and system suitability
tests.
Pre-programmed methods for performance checks built
into Metrohm instruments.
Please see also Support
or contact your Metrohm supplier for further information.
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PQ
Performance Qualification
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Routine operation
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User
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Periodic checks:
- Specifications
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Specific system suitability tests, e.g.
checking the customer-specific methods using a reference
substance.
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Analysis of reference samples.
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