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Quality needs to be designed into a product - it cannot be tested into it.


Qualification of process equipment

Did you purchase a new equipment? Do you plan serialisation (Track and Trace) and do you need to qualify your equipment and want to know how? Do you want to perform qualification according to FDA, EMA or GxP?

We support you in establishment of the

  • Qualification plan
  • Risk analysis
  • URS (User Requirement Specification)
  • Functional specification
  • Design qualification (DQ)
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process qualification (PQ)
  • Final report

Qualification of analytical equipment

Do you plan to purchase a new equipment for your GLP/GMP laboratory? Do you require assistance or do you experience a bottleneck in ressources for the generation of the corresponding documents?

We support you and generate and/or review all needed documentation or parts of it.