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Tag: GAMP

Posted on 21.06.201321.06.2013

21 CFR Part 11: References & History

 

As Part 11 solution provider CCS provides this reference listing:

  • 21 CFR Part 11 – Final Rule – OPEN HTML
  • ISPE White Paper – Part 11 – OPEN PDF
  • Guidance for Industry – Scope and Applications – OPEN PDF  
  • FDA announcement 08-July-2010 (21 CFR Part 11)

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"Draft PIC/S Good Practices for Data Management and Integrity" - Computerised Systems 21 CFR Part 11 AIDE MEMOIRE - Annex 11: ZLG_AM_QS_07121202 ANNEX 11 audid trail review audit trail CCS CPP CQA data integrity EUDRALEX GAMP ISPE QbD retrospective computer system validation revision January 2011

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