3. Conclusion
Initially devolved to the pharmaceutical industry, the structuring of qualification into QC, IQ, QO and QP stages is being deployed in other sectors of activity where these acronyms are making their appearance: sterilization of health products, biobanking, etc. This structuring is also applicable to all equipment set up by the laboratory and by the company. This structuring is also applicable to all equipment installed by the laboratory and the company.
Complemented by best practices, such as IS mapping or data exchange flows, qualification must strive to remain an agile process, with documented information limited to just what is necessary. The need to maintain data integrity is, likewise, paramount in the context of Industry 4.0, where accurate and reliable data can be leveraged with new artificial intelligence tools.
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Conclusion
Glossary
Bibliography
Standards and norms
- Quality management systems – Basic principles and vocabulary. - ISO 9000 - 2015
- Quality management systems – Requirements - ISO 9001 - 2015
- Conformity assessment – Vocabulary and general principles. - ISO/IEC 17000 - 2020
- Safety and resilience – Business continuity management systems – Requirements - ISO 22301 - 2019
- Exigences générales concernant la compétence des laboratoires d'étalonnages...
Regulations
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (2016)
Law no. 2018-493 of June 20, 2018 on the protection of personal data
Directory
Laboratories – Design offices – Schools – Research centers (non-exhaustive list)
French Information Systems Security Agency (ANSSI) https://www.ssi.gouv.fr/
French Data Protection Authority (CNIL) https://www.cnil.fr/fr
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