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A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd
Computer validation
The following articles on this topic have been published in
CRAdvisor (CRA)
– the year, issue number and starting page number for each are listed
below:
Back to Index |
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2007 |
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CRA 2007; 189:5 |
Risk-based computer system validation and Part 11 compliance. |
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CRA 2007; 191:1 |
New FDA guidance on computerised systems. |
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CRA 2007; 192:2 |
New FDA guidance on "computerized systems used in clinical investigations". |
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2005 |
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CRA 2005; 152:7 |
New guide on electronic records. |
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2002 |
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CRA 2002; 88:4 |
News and views of 21 CFR Part 11 and system validations. |
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CRA 2002; 101:1 |
FDA publishes Notes for Guidance on maintaining electronic records. |
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1998 |
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CRA 1998; 7:2 |
Computer validation becomes target for inspections. |