From: Bosshard, Peter {PTQ~Basel} [PETER.BOSSHARD@Roche.COM] Sent: Tuesday, December 03, 2002 11:27 AM To: fdadockets@oc.fda.gov Cc: PMOTISE@ORA.FDA.GOV; Schumacher, Wolfgang {PGS~Basel} Subject: Comments for Docket 00D-1539 Sirs, Please find attached our comments regarding Comments regarding Your Draft Guidance: "Electronic Records; Electronic Signatures, Maintenance of Electronic Records" (Docket No. 00D-1539). The signed original will follow tomorrow by courried. <> Best regards Peter Bosshard F. Hoffmann - La Roche AG, CH-4070 Basel / Switzerland Global Quality, Building 74 / 2 OgW 223 Tel. + 41 61 688 4608, Fax. + 41 61 688 8892