LEADER 01872nam  2200421Ia 450 
001 9910698905103321
005 20090727154356.0
035   $a(CKB)5470000002398829
035   $a(OCoLC)427904766
035   $a(EXLCZ)995470000002398829
100   $a20090727d2001      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $e21 CFR part 11, electronic records, electronic signatures, validation
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs :$cCenter for Biologics Evaluation and Research :$cCenter for Drug Evaluation and Research :$cCenter for Devices and Radiological Health :$cCenter for Food Safety and Applied Nutrition :$cCenter for Veterinary Medicine,$d[2001]
215   $aiii, 21 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on July 27, 2009).
300   $a"Draft guidance".
300   $a"August 2001".
320   $aIncludes bibliographical references (pages 15-21).
517   $aGuidance for industry 
606   $aElectronic records$xGovernment policy$zUnited States
615  0$aElectronic records$xGovernment policy
712 02$aUnited States.$bFood and Drug Administration.$bOffice of Regulatory Affairs.
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Food Safety and Applied Nutrition (U.S.)
712 02$aCenter for Veterinary Medicine (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698905103321
996   $aGuidance for industry$93434577
997   $aUNINA