Management of Functional Equivalence and Replacement Parts

What this document is for

The strategic management of part equivalence is fundamental to maintaining the operational integrity and validated state of manufacturing systems.

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Ships as

Grounded in

FDA 21 CFR 210/211 and Part 11, EU GMP (EudraLex Volume 4, including Annex 1 and Annex 11), ICH Q7–Q12, and WHO GMP. Supplied in 13 languages.

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