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Qualification

The efficient and target-oriented handling of qualification projects is our mission. Whether consulting, project support / project coordination, preparation of GMP/GXP documents, our technical experts always ensure compliance with your standards and legal regulations / guidelines. We think outside the box to save you time and money.


Our scope of services includes the qualification of:

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  • Production equipment

  • Laboratory equipment

  • HVAC systems

  • Cleanrooms

  • Storage rooms

  • Cooling units / climatic chambers / incubators / freezing units

  • (Ultra-pure) media

  • Special machines

 

The following documents are prepared in accordance with the requirements of the currently valid regulations / guidelines as well as the customer's internal standards:

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  • User requirement specifications (URS)

  • Functional specification (FS) (support and communication with potential suppliers)

  • Design Qualification (DQ) (support in the selection of the supplier)

  • Risk analysis (RA) (if necessary, as part of a workshop)

  • Installation qualification (IQ)

  • Functional qualification (OQ)

  • Performance qualification (PQ)

  • Traceability matrices

  • Change management

  • Deviation reports

  • Requalifications

  • Routine qualifications

  • FAT / SAT plans (support / supervision during implementation)

  • Creation of project-specific master plans

  • Other required documents such as maintenance plans, measuring point list, calibration plans, operating procedures, etc.

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Furthermore, we also support you in preparing for and carrying out audits.


Let us qualify your systems smartly and professionally!

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