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00D-1538:  Electronic Records; Electronic Signatures, Validation
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
Electronic Format
C 8 12/19/01 Advanced Med. Technology Association Bernie Liebler       pdf
C 7 12/19/01 F Hoffmann-La Roche Ltd (Basel) Peter Bosshard & Wolfgang Schumacher         pdf
C 6 12/19/01 Merck & Co. Inc. Bonnie J Goldmann MD        pdf
C 5 12/17/01 Merck KGaA Darmstadt (Germany) Dr Christian Heiss         pdf
C 4 12/17/01 Ray Miller  Ray Miller         pdf
C 3 12/05/01 Genzyme Corporation Robert E Yocher         pdf
LST 6 10/24/01 General References for Guidance Document (Replaces LST5)            pdf

Cover Memo txt
List doc

C 2 11/30/01 Invivodata Inc Jean Paty         pdf
C 1 11/14/01 Bruce L Hogle Bruce L Hogle         pdf
MM 19 09/20/01 HFC-230 & Sartorius Inc (08/24/01) Tom M Chin       pdf

txt

MM 18 09/20/01 HC-240 & Scientific Software Inc (08/02/01) Paul Motise         pdf

htm

MM 17 09/19/01 HFC-240 & Ionics Instruments (09/06/01) Paul Motise        pdf

htm

MM 16 09/19/01 HFC-240 & Prelude Computer Solutions Inc (08/09/01) Paul Motise         pdf

Part 1 htm Part 2 pdf Part 3  pdf

MM 15 09/19/01 HFC-240 & Datatrak International Inc (07/26/01) Paul Motise         pdf

htm

MM 14 09/19/01 HFC-240 & NuGenesis Technologies Corp (07/19/01) Paul Motise         pdf

htm

RPT 6 09/12/01 NIST National Institute of Standards & Technology                 pdf
LST 5 08/30/01 General References for Guidance Document             pdf

htm

LST 4 08/30/01 General References for Guidance Document (Superceded by LST5)                
NAD 1 09/21/01         09/24/01 48886 pdf

htm

GDL 1 09/20/01 Draft Guidance             pdf

htm   doc


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Page last updated: August 11, 2003