电子记录.人们期望与未来的FDA接收单位就 详细的(举例来说,传送的方法、媒体、 文件格式和技术协议)怎样和是否进行 电子的提交物进行协商.Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of...
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 ...
Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be 和其他的 FDA 规则所求的一般签名。除 equivalent to full handwritten signatures, initials, 非被从 1997 年 8 月 20 日起(包括该日) and ...
regulationsasspecifiedintheFDA21CFRPart11Rule. SolidWorksEnterprisePDMcanhelpreducetime,costsandrisksassociatedwiththeprocessofimplementing andvalidatingtheprocessforcompaniestocomplywiththeFDArules. Approvalprocesseswithdoubleelectronicsignaturesandfullaudittrailshelpcompaniesusethis ...
使用电子签名者,在使用之前或使用时,应向FDA证明,自1997年8月20日起其他们系统所用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), 12420 Parklawn ...
or any other country – that are required to register with FDA as food facilities because they manufacture/process, pack, or hold human food for consumption in the U.S. (21 CFR 121.1) A. Definitions The IA rule uses a number of terms in very specific ways. A full list of these terms...
(c) Where electronic signatures andtheir associated electronic records meet the requirements of this part, theagency will consider the electronic signatures to be equivalent to fullhandwritten signatures, initials, and other general signings as required byagency regulations, unless specifically excepted by...
(b)This partapplies torecordsinelectronicformthatarecreated,modified,maintained,archived, retrieved,or transmitted,under anyrecordsrequirementssetforthinagencyregulations.Thispartalsoappliestoelectronic records submittedto the agencyunder requirementsoftheFederalFood,Drug, andCosmeticActandthePublicHealthServiceAct,...
form without paper records and theagency receiving unit(s) (e.g., specific center, office, division, branch) towhich such submissions may be made. Documents to agency receiving unit(s) notspecified in the public docket will not be considered as official if they aresubmitted in electronic ...
FDA auditors/inspectors can arrive unannounced. In the course of an audit/inspection, there is ample opportunity to find observations where certain practices in the course of business do not match written requirements. These can escalate into a formal issuance ofForm 483at the...