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Guideline	Date into Effect	Organisation	Status	Link
Annex 11 - Computerised Systems GMP + GDP Qualification & Validation Software	-	EMA		View timeline
Annex 15 - Qualification and Validation This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. GMP + GDP Qualification & Validation	-	EMA		View timeline

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