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本帖最后由 lzw0813 于 2019-10-1 17:06 编辑
Regulations forCSV and Data Integrity
EU 1. Annex15: Qualification and Validation 2. Annex11: Computerised Systems
EMA 3. EMA’sGuidance on Data Integrity 4. EUGMP guide annexes: Supplementary requirements: Annex 11: Computerized systems
US FDA 5. DataIntegrity and Compliance with Drug CGMP Questions and Answers Guidance forIndustry 6. GeneralPrinciples of Software Validation 7. Guidancefor Industry Part 11, Electronic Records; Electronic Signatures — Scope andApplication 8. 21CFR Part 11 Electronic Records; Electronic Signatures
WHO 9. Guidanceon good data and record management practices
MHRA 10. GXP’Data Integrity Guidance and Definitions
PIC/S 11. Goodpractices for data management and integrity in regulated gmp/gdp Environments 12. Goodpractices for Computerised systems in regulated “gxp” environments
EPA 13. Guidanceon Environmental Data Verification and Data Validation
PDA 14. DataIntegrity
OECD 15. Applicationof GLP Principles to Computerised Systems
TGA 16. DataManagement and Data Integrity (DMDI) 17. Computerisedsystems (Annex 11)
ISPE 18. GAMPGAMP Guide: Records & Data Integrity 19. GAMPGAMP 5 Guide: Compliant GxP Computerized Systems
ISPE 书籍需要请联系:QQ:1062707049 WX: AL-Service(添加时备注:ISPE)
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