INSTRUMENT VALIDATION FOR REGULATED STUDIES - Flow Cytometry in Drug Discovery and Development - page 269

Food Safety andAppliedNutrition (CFSAN), Center for VeterinaryMedicine (CVM), Office
of Regulatory Affairs (ORA), 2003, pp. 1-9. Available at http://www.21cfrpart11.com/files/
fda_docs/guide_doc_scope_appFeb2003.pdf. Accessed Jan. 13, 2009.
2. Title 42 Code of Federal Regulations, Pt 493. Centers for Medicare and Medicaid Services,
Department of Health andHuman Services. Available at http://wwwn.cdc.gov/clia/regs/toc.
aspx. Accessed Jan. 13, 2010.
3. Dorsey D. B. Evolving concepts of quality in laboratory practice: a historical overview of
quality assurance in clinical laboratories. Arch. Pathol. Lab. Med. 1989;113(12):

1329-1334.
4. Kaplan AH. Fifty years of drug amendments revisited: in easy-to-swallow capsule form.
Food Drug Law J. 1995;50(Special Issue):179-196.
5. OECD Principles of Good Laboratory Practice, Organisation for Economic Co-operation
and Development, 1998, pp. 1-41. Available at http://www.olis.oecd.org/olis/1998doc.nsf/
LinkTo/NT00000C5A/$FILE/01E88455.PDF. Accessed Jan. 13, 2010.
6. General Principles of Software Validation: Final Guidance for Industry and FDA Staff, U.S.
Department of Health and Human Services, Food and Drug Administration, Center
for Devices and Radiological Health, Center for Biologics Evaluation and Research,
2002, pp. 1-43. Available at http://www.fda.gov/downloads/MedicalDevices/Device
RegulationandGuidance/GuidanceDocuments/ucm085371.pdf. Accessed Jan. 13, 2010.
7. Guidance for Industry. Part 11, Electronic Records: Electronic Signatures - Scope and
Application, U.S. Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics
Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH),
Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine
(CVM), Office of Regulatory Affairs (ORA), 2003, pp. 1-9. Available at http://www.21
cfrpart11.com/files/fda_docs/part11_final_guidanceSep2003.pdf. Accessed Jan. 13, 2009.
8. Guideline for Good Clinical Practice, ICH Harmonised Tripartite Guideline, ICH Expert
Working Group, 1996 pp. 1-53. Available at http://www.ich.org/LOB/media/MEDIA482.
pdf. Accessed Jan. 13, 2010.