Quality Assurance Useful Links

Guide to Inspections of Quality Systems

http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm

Good Laboratory Practice for Nonclinical Laboratory Studies

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

Quality System Regulation

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

Electronic records and signatures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Basics of Auditing for Regulators

http://www.fda.gov/ora/training/orau/state/basics_auditing.htm

Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers – General Requirements

http://www.fda.gov/ohrms/dockets/98fr/04d-0001-bkg0001-12-99-28genreq.pdf

FDA/ORA Quality Manual

http://www.fda.gov/ora/about/qualitymanual/default.htm

FDA/CFSAN Laboratory Quality Assurance Manual

http://www.cfsan.fda.gov/~comm/qam-toc.html

Good Manufacturing Practice / Quality Systems

http://www.fda.gov/cdrh/comp/gmp.html

Guideline on General Principles of Process Validation

http://www.fda.gov/cdrh/ode/425.pdf

Good Clinical Practice

http://www.fda.gov/cder/guidance/959fnl.pdf