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Quality Assurance Approval of Item Masters in ERP

Quality SystemsQuality AssuranceFormSOP

What this document is for

The integrity of the Item Master (IM) within an Enterprise Resource Planning (ERP) system is a fundamental component of maintaining a validated state in pharmaceutical manufacturing.

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Ships as

Document typeCode
SOPSOP-QMS-024
FormFRM-QMS-028

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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