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lundi 18 novembre 2019

Revisited - Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

An interesting article published in the ECA's GMP News on November 13, 2019, https://www.gmp-compliance.org/gmp-news/data-integrity-for-analytical-instruments-connected-to-a-lims-via-a-middleware

The objective of the article published in ECA's GMP News is to explain how to manage data integrity to analytical devices connected to a LIMS via middleware.

The inquiry originating this article is: "The first data (raw data) is generated internally, processed in the middleware and sent to the LIMS. However, the manufacturer does not allow access to the original data in the automated analyser."

The objective of this article is to provide the authors' point of view to the advice provided in the ECA's GMP News article using as an example a typical manufacturing architecture.

Plus d'information ici.

Orlando Lopez

Orlando Lopez

E-Compliance and E-Records Integrity SME