签名者使用电子签名前或使用时应向FDA证明,从1997年8月20日起及以后在他们系统上的电子签名,与传统的手写签名有同等的法律效力 (1)The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane,...
46、andwritten signatures.签名者使用电子签名前或使用时应向 FDA 证明,从 1997年 8 月 20日起及以后在他们系统上 的电子签名,与传统的手写签名有同等的法律效力(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations...
签名者使用电子签名前或使用时应向FDA证明,从1997年8月20日起及以后在他们系统上的电子签名,与传统的手写签名有同等的法律效力 (1)The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane,...
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal ...
Full compliance for 21 CFR part 11 and EU Annex 11 is supported now by LabX. The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. 21CFR Part 11 a...
本条款的规则提供了标准,在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。 (b)This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records ...
签名者使用电子签名前或使用时应向FDA证明,从1997年8月20日起及以后在他们系统上的电子签名,与传统的手写签名有同等的法律效力 (1)The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane,...
Part 11 applies to persons who, in fulfillment of a requirement in a statute or regulation, have chosen to maintain records or submit designated information electronically to the FDA, and to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted ...
(b)This partapplies torecordsinelectronicformthatarecreated,modified,maintained,archived, retrieved,or transmitted,under anyrecordsrequirementssetforthinagencyregulations. Thispartalsoappliestoelectronic records submittedto the agencyunder requirementsoftheFederalFood,Drug, andCosmeticActandthePublicHealthServiceAct...
for submission in electronic form without paper for submission in electronic form without paper FDA FDA接收单位 (举例来说,特定的中心, 接收单位 (举例来说,特定的中心, records and the agency receiving unit(s) (e.g., records and the ...