Biomedical Engineering Reference
In-Depth Information
In conclusion, there is no reason why free/open source software cannot
be validated and used in support of regulatory signifi cant business
operations - it just may not be as simple, quick and inexpensive as it fi rst
appears.
21.9 References
[1] See http://www.simulations-plus.com/
[2] See http://www.opencrx.org/
[3] See http://www.linkedin.com/
[4] US Code of Federal Regulations, Title 21 Part 211 ' Current Good
Manufacturing Practice for Finished Pharmaceuticals '.
[5] US Code of Federal Regulations, Title 21 Part 820 ' Quality System
Regulation' (Medical Devices) .
[6] European Union Eudralex Vol 4 (Good manufacturing practice (GMP)
Guidelines), Annex 11 (Computerised Systems) .
[7] Pharmaceutical Inspection Co-operation Scheme PI-011 ' Good Practices
For Computerised Systems In Regulated GxP Environments ' (See http://
www.picscheme.org/ ).
[8] Ref ISO 13485:2003 ' Medical devices — Quality management systems —
Requirements for regulatory purposes ' (see http://www.iso.org/ ).
[9] US FDA ' General Principles of Software Validation ', 11 January 2002 (see
http://www.fda.gov ).
[10] See US FDA website at http://www.fda.gov/ for examples of Consent
Decrees.
[11] GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized
Systems , February 2008 (published by ISPE - see http://www.ispe.org/ )
[12] See http://www.knime.org/
[13] See http://jas.freehep.org/jas3/
[14] See http://rdkit.org/
[15] See http://www.bioconductor.org/
[16] See http://www.bioperl.org/
[17] See http://biojava.org/
[18] See http://bioclipse.net/
[19] See http://emboss.sourceforge.net/
[20] See http://www.taverna.org.uk/
[21] See http://ugene.unipro.ru/
[22] The R Foundation for Statistical Computing - see http://www.r-project.org/
foundation/
[23] US Code of Federal Regulations, Title 21 Part 11 ' Electronic Records and
Signatures '.
[24] See http://otrs.org/
[25] See http://www.project-open.com/en/solutions/itsm/index.html
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