Quadra 4 Operator Manual
Tomtec
152
(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 Food, Drug, and Cosmetic Act and the Public Health
Service Act, even if such records are not specifically identified in agency regulations.
However, this part does not apply to paper records that are, or have been, transmitted
by electronic means.
(c) Where electronic signatures and their associated electronic records meet the
requirements of this part, the agency will consider the electronic signatures to be
equivalent to full handwritten signatures, initials, and other general signing's as required
by agency regulations, unless specifically excepted by regulation(s) effective on or after
August 20, 1997.
(d) Electronic records that meet the requirements of this part may be used in lieu of
paper records, in accordance with 11.2, unless paper records are specifically required.
(e) 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.
[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]
Sec. 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;
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