FDA inspection

 Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.

 

(f) This part does not apply to records required to be established or maintained by §§ 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(g) This part does not apply to electronic signatures obtained under § 101.11(d) of this chapter.

 

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

 

(i) This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(j) This part does not apply to records required to be established or maintained by part 507 of this chapter. Records that satisfy the requirements of part 507 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(k) This part does not apply to records required to be established or maintained by part 112 of this chapter. Records that satisfy the requirements of part 112 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(l) This part does not apply to records required to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the requirements of subpart L of  fda 21 cfr part 11 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(m) This part does not apply to records required to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(n) This part does not apply to records required to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the requirements of subpart O of part 1 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

(o) This part does not apply to records required to be established or maintained by part 121 of this chapter. Records that satisfy the requirements of part 121 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part.

 

[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004; 79 FR 71253, 71291, Dec. 1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, 56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27, 2015; 81 FR 20170, Apr. 6, 2016; 81 FR 34218, May 27, 2016]

 

§ 11.2 Implementation.

 

(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.

 

(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:

 

(1) The requirements of this part are met; and

 

(2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. 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 such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.

 

§ 11.3 Definitions.

 

(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.