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prestationskvalifikation (PQ)

performance qualification [ENGLISH]

Documented verification process to confirm that a piece of technology or equipment, such as a device, apparatus, machine or system, consistently performs within an accepted range under routine conditions.

prestationskvalifikation [SWEDISH]

Dokumenterad verifieringsprocess för att bekräfta att en del av teknik eller utrustning, såsom en enhet, apparat, maskin eller system, konsekvent presterar inom ett accepterat intervall under rutinmässiga förhållanden.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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