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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