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Available Guidelines
4 matches
| Guideline | Date into Effect | Organization | Status | Link |
|---|---|---|---|---|
| Annex 11 - Computerised Systems | - | |||
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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. |
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Annex 6 - Manufacture of Medicinal Gases
This Annex deals with the manufacture of active substance gases and with the manufacture of medicinal gases. |
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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. |
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