Richtlinien EU GAMP® 5 EudraLex Annex 11 EU-GMP Guideline Chapter 4: Documentation Anforderungen an die Aufbewahrung elektronischer Daten Anforderungen an elektronische Unterschriften und Handzeichen ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q9: Quality Risk Management Q10: Pharmaceutical Quality System FDA 21 CFR Part 11 21 CFR Part 210 21 CFR Part 211 21 CFR Part 820 General Principles of Software Validation Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Blood Establishment Computer System Validation in the User’s Facility Electronic Source Data in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations Andere PIC/S: Good Practices for computerised Systems in regulated „GxP“ Environments Kontakt aufnehmen
