FDA 21 CFR 11 Agilent OpenLAB CDS 2.1 (Code of Federal Regulations, CFR) 21 US FDA EU Eudralex 4 11 21 CFR 1997 1999 Agilent OpenLAB CDS 2.1 OpenLAB CDS LC GC LC/MS GC/MS A/D OpenLAB CDS OpenLAB CDS (SOP) 1 OpenLAB CDS 2.1 21 CFR EU 21 CFR Part 11.3(b)(4)
21 CFR 21 CFR (11.10(d) (i) (g) 11.100(b)) 21 CFR Botha Eloff IBM [1] 2
1. US FDA 21 CFR Part 11 OpenLAB CDS 2.1 1 21 CFR US FDA [2] EU [3] Part 11 21 CFR Part 11 21 CFR S U OpenLAB CDS 2.1 N/A CDS OpenLAB CDS 2.1 1. 11.10(a) S, U / OpenLAB CDS 1.1 S, U OpenLAB CDS 2.1 Agilent OpenLAB CDS 1.2 U. B GMP 577 N/A / OpenLAB CDS 3
2. 11.10(b) S, U / OpenLAB CDS 2.1 S PDF FDA 2.2 S.8.1 PDF GMP 583 2.3 S, U 585.2 OpenLAB CDS 11.10(c) 2.4 2.5 2.6 2.7 S, U GMP 163 OpenLAB CDS U.17 N/A S, U.17 OpenLAB CDS S, U.7.1 GMP 584 4
2. S, U / OpenLAB CDS 2.8 S F2 / FDA FDA 2.9 FDA U F2 N/A / / FDA 2.10 S.7.1 OpenLAB GMP 163 CDS GMP 585 Part 211, 68 b 2.11 2.12 2.13 U.7.2 GMP 163 GMP 585 Part 211, 68 b N/A S, U E OpenLAB CDS 2.1 FTP FTP CDS FTP S, U F OpenLAB CDS 2.1 3. S, U / OpenLAB CDS 3.1 S, U GMP 183 163 ID 11.10(d) GMP 579, ICH Q7.5.43 ID 3.2 ID 3.3 S, U ID ID S, U 4 OpenLAB CDS Windows 5
4. S, U / OpenLAB CDS 4.1 S GMP 163 11.10(e) FDA GLP FDA GMP 11.10(e) 11.10(e) 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 S FDA 21 CFF 58.130 e 2 3 ID S, 8.2 OpenLAB CDS 2.1 S Part 211.194 8b S, U S, 9 S OpenLAB CDS 2.1 S S, U 6
4. 11.10(e) S, U / OpenLAB CDS 4.11 S FDA 4.12 S, 8.1 5. 11.10(f) S, U / OpenLAB CDS 5.1 S 1. 11.10(g) 11.10(h) 5.2? 5.3 5.4 2. 3. 4. 5. 6. S Part 211, 68 b S, 12.4 S 1. 1. 2. OpenLAB CDS 2.1 LC MS 2. 7
5. 11.10(i) 11.10(j) 11.10(k) 11.10(i) S, U / OpenLAB CDS 5.5 / 5.6 5.7 5.8 (1) (2) 5.9 U GMP 18 571 N/A OpenLAB CDS U N/A (SOP) U 11.10(j) N/A U GMP 161 N/A S, U OpenLAB CDS 6. S, U / OpenLAB CDS 6.1 S.5 N/A OpenLAB CDS 8
6. S, U / OpenLAB CDS 6.2 S, U -6 OpenLAB CDS GMP 580 ICHQ7-5.45 l 6.3 6.4 6.5 S, U D.3 S D.3 S, U D.3 No OpenLAB CDS 2.1 (UTC)/ (GMT) 7. 11.30 11.30 S, U / OpenLAB CDS 7.1 S, U N/A OpenLAB CDS 21 CFR.3(b) (9) 7.2 S N/A OpenLAB CDS 21 CFR.3(b) (9) 9
8. / 11.50 (a) S, U / OpenLAB CDS 8.1 8.2 S, U.14 ICH Q7.6.18 S 11.50 (b) 11.70 (1) (2) (3) ) 8.3 (a)(1) (a)(2) (a)(3) 8.4 8.5 S S S 124 10
9. 11.100(a) 11.100(b) 11.100 (c) S, U / OpenLAB CDS 9.1 S, U 9.2 U N/A 9.3 U N/A 1997 8 20 11.200(a) (1) 11.200(a) (1) (i) 11.200(a) (1) (i) 11.200(a) (1) (ii) 9.4 9.5 9.6 9.7 9.8 S, U ID S ID S ID S ID 11
9. 11.200(a) (2) 11.200(a) (3) 11.200(b) S, U / OpenLAB CDS 9.9 S ID 9.10 S, U 9.11 S N/A OpenLAB CDS 2.1 10. 11.300(a) 11.300(b) 11.300(c) S, U / OpenLAB CDS 10.1 S, U OpenLAB CDS ID 10.2 S, U Windows ( ) 10.3 U N/A 12
10. 11.300(d) 11.300(e) S, U / OpenLAB CDS 10.4 U N/A / 10.5 U N/A 11. S, U / OpenLAB CDS 11.1 S, U 4.5 OpenLAB CDS ISO 9001 GMP 577 LSCA GAMP 2.2 agilent.com/quality (QMS) 11.2 S, U GMP 589 LSCA 7.4 agilent.com/quality 13
11. ICH Q10 ICH Q10 11.10(i) S, U / OpenLAB CDS 11.3 S, U ICHQ10, 2.7 c LSCA 7.4 agilent.com/quality 11.4 S, U ICHQ10, 2.7 c LSCA 7.4 agilent.com/ quality 11.5 S, U LSCA 6.0 agilent.com/ quality 14
1. R. A. Botha and J. H. P Eloff. Separation of duties for access control enforcement in workflow environments. IBM Systems Journal End-to-end security. 40 (3), 666-682. (2001). 2. U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21. Title 21 Food and Drugs, Chapter I Food and Drug Administration Department of Health and Human Services, Subchapter A General. Part 11 Electronic Records; Electronics Signatures [Online] https://www. accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/cfrsearch. cfm?cfrpart=11 (accessed November 4, 2015). 3. European Commission Health and Consumers Directorate-General. Public Health and Risk Assessment. Pharmaceuticals. EudraLex. The Rules Governing Medicinal Products in the European Union. Volume 4. Good Manufacturing Practice. Medicinal Products for Human and Vetrinary Use. Annex 11. Computerised Systems. [Online] http://ec.europa. eu/health/files/eudralex/vol-4/ annex11_01-2011_en.pdf (accessed November 4, 2015). 15
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