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.

In addition to the...