FDA
|
|
| |
US Food and Drug Administration (FDA) |
| |
http://www.fda.gov |
| |
FDA Code of Federal Regulations; Title 21 |
| |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm |
EC
|
|
| |
European Commission (EC) |
| |
http://ec.europa.eu/index_en.htm |
| |
EudraLex Rules Governing Medicinal Products in the EC |
| |
http://ec.europa.eu/health/documents/eudralex/index_en.htm |
MHLW
|
|
| |
Japanese Ministry of Health Labor and Welfare |
| |
http://www.mhlw.go.jp/english/
|
| |
Pharmaceutical and Medical Device Agency (PDMA)
|
| |
http://www.pmda.go.jp/english/index.html
|
ICH
|
|
| |
International Conference on Harmonisation (ICH) |
| |
http://www.ich.org/
|
| |
ICH Guidelines |
| |
http://www.ich.org/products/guidelines.html |
HIPAA
|
|
| |
US Department of Health & Human Services (HHS) |
| |
http://www.hhs.gov |
| |
Health Insurance Portability and Accountability (HIPAA) |
| |
http://www.hhs.gov/ocr/hipaa/ |
SOX
|
|
| |
US Securities and Exchange Commission (SEC) |
| |
http://www.sec.gov |
| |
SEC Sarbanes-Oxley Act (SOX) |
| |
http://www.sec.gov/about/laws/soa2002.pdf |
PIC/S
|
|
| |
Pharmaceutical Inspection Cooperation Scheme (PIC/S) |
| |
http://www.picscheme.org/index.php |
| |
PIC/S Publications
|
| |
http://www.picscheme.org/publication.php |
Resources
|
|
| |
Praxis Software Quality Training and Consulting Services
|
| |
http://www.praxismi.com/content/computer-system-validation-training |
| |
http://www.praxismi.com/content/computer-system-validation |
