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Richtlijn	Ingangsdatum	Organisatie	Link
Annex 11 - Computerised Systems GMP + GDP Qualification & Validation Software	-	EMA	Tijdlijn bekijken
FDA Computer Software Assurance Guidance This is an FDA guidance document titled "Computer Software Assurance for Production and Quality Management System Software," issued February 3, 2026. It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose. GMP + GDP Software Medical Devices	-	US FDA	Tijdlijn bekijken
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	Tijdlijn bekijken

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