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operativ kvalifikation (OQ)

operational qualification [ENGLISH]

Process of reviewing and documenting that a piece of technology or equipment, such as a device, apparatus, machine or system, is functioning according to the manufacturer’s design and operational specifications.

operativ kvalifikation [SWEDISH]

Process för att granska och dokumentera att en del av teknik eller utrustning, såsom en enhet, apparat, maskin eller system, fungerar enligt tillverkarens design- och driftsspecifikationer.


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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