Qualification

Targeted support and expertise for IQ, OQ, or PQ

 

The consistent quality of the products we manufacture – not to mention the reproducibility of our test processes – is fundamental to the laboratories and production facilities which operate subject to GMP or GLP requirements. The resulting obligation to provide supporting evidence requires a large number of unit tests to be carried out and recorded precisely. BINDER can help you significantly reduce the workload associated with qualifying and validating units.

 

IQ, which stands for Installation Qualification, confirms that the unit has been properly installed according to customer requirements including documentation. The technician checks that the unit has been installed correctly, as specified in the qualification folder. The qualification folders can be ordered on a unit-specific basis. 

 

OQ, or Operational Qualification, checks and confirms that the unit is operating
properly in an unloaded state. The required tests are available in the qualification folder.

 

PQ, which stands for Performance Qualification, checks and documents the unit function in the loaded state under customer-specific requirements. The required tests are defined by mutual agreement according to customer specifications.

 

Benefits

  • Reproducible data for your BINDER unit – matched to your processes and standards
  • Use of BINDER expertise during validation and qualification
  • Implementation by qualified and experienced specialists
  • Validation and qualification carried out on site

 

 

Range of services

  • Qualification folder as supporting documents for validation performed by customer Includes: IQ / OQ checklists, unit schematics, QM
  • Certificate according to ISO 9001
  • Maintenance recommendations
  • IQ / OQ of the BINDER software carried out with the connected unit
  • IQ / OQ carried out with or without light photometry

 

Just get in touch with us – we will create a proposal for you with no obligations.

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