Documente Academic
Documente Profesional
Documente Cultură
PAPER
Defining Current
Lack of permissions,
No audit trails,
No electronic signatures,
Improper or no back up,
No disaster recovery.
Reference
1. http://self.gutenberg.org/articles/Edward_Deming
2. http://www.cbsnews.com/news/ranbaxy-whistleblowerreveals-how-he-exposed-massive-pharmaceutical-fraud/ .
See also, http://www.ft.com/cms/s/0/aad84e64-574c11e3-b615-00144feabdc0.html
3. http://www.accessdata.fda.gov/scripts/inspsearch/results.
cfm?start=401&end=500&textSearch=&classification=&stat
e=&project=&inspDateEndFrom=01/01/2014&inspDateEndT
o=12/31/2014&classificationDecision=&country=&city=
&zip=¢er=&sortBy=&district= ; see also:
http://www.accessdata.fda.gov/scripts/inspsearch/results.cfm
4. http://www.pharmtech.com/data-integrity-analyticallaboratory?rel=canonical
5. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
Manufacturing/ucm169105.htm
6. http://www.pharmtech.com/data-integrity-analyticallaboratory?rel=canonical
7. http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/
ucm124787.htm
8. http://www.fda.gov/ICECI/Inspections/InspectionGuides/
ucm074918.htm
9. http://www.fda.gov/ICECI/Inspections/InspectionGuides/
ucm074918.htm
10. http://npalliance.org/blog/2014/08/29/fda-draft-guidancedistribution-risk-information-pharmaceutical-companiesfalls-short-ensuring-patient-safety/
11. http://www2.emersonprocess.com/siteadmincenter/
PM%20Articles/ART-Trust-but-Verify.pdf
12. http://www-935.ibm.com/services/us/gbs/bus/pdf/
gbe03100-usen-03-making-change-work.pdf
13. http://www.genengnews.com/gen-articles/a-new-approachto-laboratory-efficiency-on-site-instrument-conciergeservice/5296/
15. http://www-935.ibm.com/services/us/gbs/bus/pdf/
gbe03100-usen-03-making-change-work.pdf;
see also, http://www.pharmtech.com/data-integrityanalytical-laboratory?rel=canonical
14. http://www.fda.gov/downloads/Drugs/Guidances/
UCM269919.pdf
For more information on OneSource, contact your local OneSource representative or visit: www.perkinelmer.com
PerkinElmer, Inc.
940 Winter Street
Waltham, MA 02451 USA
P: (800) 762-4000 or
(+1) 203-925-4602
www.perkinelmer.com