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Batch Record

Explore practical guides and implementation patterns for this topic.

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Manufacturing Execution System (MES)

Mastering MES Change Control & Revalidation in Pharma Manufacturing

💬 In Plain Words: Once a Manufacturing Execution System (MES) is validated and running production (like batch B10025 ), you cannot simply edit the software's code because "someone asked for a new feature." Change control is the strict, governed process used to evaluate, approve, test, and document any modification. Before touching the production environment, you must ask: What could this change break? Does it compromise data integrity? What requires re-testing?
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