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Qualification

The efficient and goal-oriented implementation of qualification projects is our mission.

Whether consulting, project support/coordination, or the creation of GMP/GXP documents , our experts always ensure compliance with your standards and legal regulations/guidelines. We think outside the box to save you time and money.

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Our scope of services includes the qualification of:
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  • Production equipment

  • Laboratory equipment

  • HVAC systems

  • Cleanrooms

  • Storage rooms

  • (Ultra-pure) media

  • Cooling units / climatic chambers / incubators / freezing units

  • 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:

  • User requirement specifications (URS)

  • Functional specification (FS)

  • Design Qualification (DQ)

  • Risk analysis (RA)

  • 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.

Furthermore, we also support you in preparing for and carrying out audits.
Let us qualify your systems smartly and professionally!​

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