2. Terminology
Discrepancies appear in articles, books, symposia... when it comes to qualification and validation terminology. So, before addressing the main points of qualification, it is important to clarify the terminology to avoid confusion. The definitions of qualification given below are taken from the United States Pharmacopoeia and recognized specialist articles and books on the subject
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Terminology
Stages in device qualification
Bibliography
Standards and norms
- Calibration and verification procedure for non-automatic weighing instruments (IPENA) – Part 1: verification - FDX 07-017 - 1995
- Maintenance – Maintenance terminology - NF EN 13306 - 2010
- Geometric product specification (GPS) – Verification by measurement of parts and measuring equipment – Part 1: Decision rules for proving compliance or non-compliance with the specification - NF EN ISO 14253-1 - 2013 ...
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Organizations
French Standards Association (Afnor) http://www.afnor.org/
ASTM International http://www.astm.org/
Eurachem http://www.eurachem.org/
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