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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary Ltd21 CFR Part 11The following articles on this topic have been published in CRAdvisor (CRA) – the year, issue number and starting page number for each are listed below: |
| 2005 | |
| CRA 2005; 153:4 | Warning for investigators and sponsors to take 21 CFR Part 11 seriously. |
| 2004 | |
| CRA 2004; 130:8 | FDA to hold meeting on 21 CFR Part 11. |
| CRA 2004; 140:7 | FDA to issue further Part 11 guidance. |
| CRA 2004; 142:1 | FDA may not strictly enforce 21 CFR Part 11. |
| 2003 | |
| CRA 2003; 106:1 | Enforcement decision for 21 CFR Part 11 whilst FDA re-examines the requirements. |
| CRA 2003; 115:1 | The monitor's role in 21 CFR Part 11 compliance. |
| CRA 2003; 115:2 | Where now with 21 CFR Part 11? |
| CRA 2003; 117:2 | FDA publishes new guidance on 21 CFR Part 11, Scope and Application. |
| 2002 | |
| CRA 2002; 81:1 | Training is key to Part 11 compliance. |
| CRA 2002; 88:4 | News and views of 21 CFR Part 11 and system validations. |
| CRA 2002; 91:2 | Barriers to compliance with 21 CFR Part 11. |
| CRA 2002; 91:6 | More on electronic signatures. |
| CRA 2002; 100:6 | An overview of US regulations contained in the Code of Federal Regulations. |
| 2001 | |
| CRA 2001; 63:5 | FDA want greater compliance to 21 CFR Part 11. |
| CRA 2001; 74:3 | FDA guidance for Part 11 still unavailable. |
| CRA 2001; 77:1 | FDA releases Part 11 guidance. |
| CRA 2001; 78:2 | Towards compliance with CFR 21 Part 11. |
| CRA 2001 ; 79:6 | PDFs unacceptable for e-submission. |
| CRA 2001; 80:2 | Deviations form Part 11 result in warning letter. |