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21 CFR 11.1~11.3

更新时间:2017-08-23

21 CFR 11.1 range 20160527

 

§ 11.1 Scope. The range

 

(a) The regulations in this part The set forth thecriteria under which The agency considers electronic records, electronicsignatures, and handwritten signatures executed to electronic records to betrustworthy, reliable, and generally equivalent to paper records andhandwritten signatures executed on paper.

 

The provisions of this section to set the FDA think electronic records and electronic signatures and the handwritten signature of the implementation of electronic records are credible, reliable and often equated with paper records and signed a paper written in standard.

 

(b) This part applies to records in electronic formthat are created, modified, maintained, archived, retrieved, or transmitted,under any records requirements set forth in agency regulations. This part alsoapplies to electronic records submitted to the agency under requirements of theFederal Food, Drug, and Cosmetic Act and the Public Health Service Act, even ifsuch records are not specifically identified in agency regulations. However,this part does not apply to paper records that are, or have been, transmittedby electronic means.

 

This section is applicable to electronic form records that are created, modified, maintained, archived, retrieved or transmitted in accordance with the records set in FDA regulations. This section also applies to electronic records submitted to the FDA under the federal food and drug cosmetic act and the public health service act, even if the record is not clearly identified in FDA regulations. However, this section does not apply to paper records that will be transmitted electronically.

 

(c) Whereelectronic signatures and their associated electronic records meet the requirementsof the this part, the agency will consider the electronic signatures to beequivalent to full handwritten signatures and initials, and other general signingsas required by agency regulations, unless specifically excepted byregulation (s) effective on or after August 20, 1997.

 

If electronic signature and electronic records related to it in accordance with the requirements of this section, the FDA will think electronic signature is equivalent to completely hand signature, first letter signature, and other general signature, the desires of FDA regulations take effect on August 20, 1997 years after the laws and regulations unless explicitly exclude.

 

(d) Electronic records that meet the requirements ofthis part may be 2 in lieu of paper records, in accordance with § 11.2, unless paper records are specifically required.

 

In addition to the special requires the use of paper records, on the basis of § 11.2, to meet the requirements of this section electronic records can be used to replace paper records.

 

(e) Computersystems (including hardware and software), controls, and attendantdocumentation maintained under this part shall be available for, andsubject to, FDA inspection.

 

Computer systems (including hardware and software), control, and accompanying documents which are required to be maintained in this section shall be available during FDA inspection.

 

(f) This part does not apply to records required to beestablished or maintained by § § 1.326 through 1.368 of This chapter. The Recordsthat the satisfy the requirements of part 1, subpart J of This chapter, but thatalso are required under other applicable statutory provisions or regulations, remain subject to This part.

 

This section does not apply to under this chapter § § 1.326 to § § 1.368 requirements and establish or maintain records. This chapter § § 1.326 to § § 1.368 required records, such as also need other applicable laws and regulations clause, will still have to meet the requirements of this section.

 

(g) This partdoes not apply to electronic signatures obtained under § 101.11 (d) of thischapter.

 

This section in this chapter shall not apply to § 101.11 (d) of electronic signature.

 

 

 

(h) This part does not apply to electronic signaturesobtained under § 101.8 (d) of This chapter.

 

This section in this chapter shall not apply to § 101.8 (d) of electronic signature.

 

 

 

(I) This part does not apply to records required to beestablished or maintained by part 117 of This chapter. The records that the satisfy therequirements of part 117 of This chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

 

This section is not applicable to the records set up and kept in accordance with part 117 of this chapter. The records requested in part 117 of this chapter shall be subject to the requirements of this section, if applicable to other applicable laws and regulations.

 

 

 

(j) This part does not apply to records required to beestablished or maintained by part 507 of This chapter. The records that the satisfy therequirements of part 507 of This chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

 

This section is not applicable to the records set up and kept in accordance with part 507 of this chapter. The records requested in part 507 of this chapter shall be subject to the requirements of this section, if applicable to other applicable laws and regulations.

 

 

 

(k) This part does not apply to records required to beestablished or maintained by part 112 of This chapter. The records that the satisfy therequirements of part 112 of This chapter, but that also are required underother applicable statutory provisions or regulations, remain subject to thispart.

 

This section is not applicable to the records set up and kept in accordance with section 112 of this chapter. The records requested in part 112 of this chapter shall be subject to the requirements of this section, if applicable to other applicable laws and regulations.

 

 

 

(l) This part does not apply to records required to beestablished or maintained by subpart l of part 1 of This chapter. Records thatsatisfy the requirements of subpart l of part 1 of This chapter, but that alsoare required under other applicable provisions or regulations, remainsubject to This part.

 

This section is not applicable to the records set up and saved according to the requirements of section L of part 1 of this chapter. The records requested by part L of section 1 of this chapter, as required by other applicable laws and regulations, shall remain in conformity with the requirements of this section.

 

 

 

(m) This part does not apply to records required to beestablished or maintained by subpart 1 of This chapter. Records thatsatisfy the requirements of subpart m of part 1 of This chapter, but that alsoare required under other applicable provisions or regulations, remainsubject to This part.

 

This section is not applicable to the records set up and saved according to the requirements of section M of part 1 of this chapter. The records requested by part M of section 1 of this chapter, as required by other applicable laws and regulations, shall remain in conformity with the requirements of this section.

 

 

 

(n) This part does not apply to records required to beestablished or maintained by subpart O of This chapter. Records thatsatisfy the requirements of subpart O of This chapter, but that alsoare required under other applicable provisions or regulations, remainsubject to This part.

 

This section is not applicable to the records set up and kept in accordance with the requirements of part O of part I of this chapter. The records requested by part O, part O, part O of this chapter shall be subject to the requirements of this section, if applicable to other applicable laws and regulations.

 

 

 

(o) This part does not apply to records required to beesta

 
 
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