Understanding 21 CFR Part 11 and its application in analytical labs

18 Jul 2021

In this expert resource, produced by SelectScience in association with Cytiva, we explore the 21 CFR Part 11 regulations issued by the U.S. Food & Drug Administration (FDA) and outline the responsibility of GxP lab users to understand and interpret these guidelines and validate relevant processes to ensure compliance.

Amersham ImageQuant 800 systems

Cytiva

Flexible imagers with automated features for sensitive, accurate chemiluminescence and fluorescence detection. To support your electronic data management, an optional GxP module is available, designed to meet increasing requirements of regulations like FDA 21 CFR part 11 and EU GMP Annex 11.

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