Development and Maintenance of Detailed Design and Configuration Specifications

What this document is for

The Detailed Design Specification (DDS) serves as a strategic cornerstone within the GxP (Good Practice) lifecycle.

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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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