Part 11

Part 11-Electronic Records:

Electronic Records Posted On
Posted By ningsoftwarfmy

The regulations in this part set forth the criteria under which the agency considers electronic records, electronic autographs, and handwritten autographs executed to electronic records to be secure, dependable, and generally original to paper records and handwritten autographs executed on paper.

This part applies to records in electronic form that are created, modified, maintained, archived, recaptured, or transmitted, under any records conditions set forth in agency regulations. This part also applies to electronic records submitted to the agency under conditions of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, indeed if similar records aren’t specifically linked in agency regulations. Still, this part doesn’t apply to paper records that are, or have been, transmitted by electronic means.

Where electronic autographs and their associated electronic records meet the conditions of this part, the agency will consider the electronic autographs to be original to full handwritten autographs, initials, and other general signings as needed by agency regulations, unless specifically excepted by regulation (s) effective on or after August 20, 1997.

Electronic records that meet the conditions of this part may be used in lieu of paper records, in agreement with§11.2, unless paper records are specifically needed.

Computer systems ( including tackle and software), controls, and attendant attestation maintained under this part shall be readily available for, and subject to, FDA examination.

This part doesn’t apply to records needed to be established or maintained by§§1.326 through1.368 of this chapter. Records that satisfy the conditions of part 1, subpart J of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to electronic autographs attained under§101.11 (d) of this chapter.

This part doesn’t apply to electronic autographs attained under§101.8 (d) of this chapter.

This part doesn’t apply to records needed to be established or maintained by part 117 of this chapter. Records that satisfy the conditions of part 117 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to records needed to be established or maintained by part 507 of this chapter. Records that satisfy the conditions of part 507 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to records needed to be established or maintained by part 112 of this chapter. Records that satisfy the conditions of part 112 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to records needed to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the conditions of subpart L of part 1 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to records needed to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the conditions of subpart M of part 1 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

 

This part doesn’t apply to records needed to be established or maintained by subpart O of part 1 of this chapter. Records that satisfy the conditions of subpart O of part 1 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

This part doesn’t apply to records needed to be established or maintained by part 121 of this chapter. Records that satisfy the conditions of part 121 of this chapter, but that also are needed under other applicable statutory vittles or regulations, remain subject to this part.

§11.2 Perpetration:

For records needed to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic autographs in lieu of traditional autographs, in whole or in part, handed that the conditions of this part are met.

For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic autographs in lieu of traditional autographs, in whole or in part, handed that

.The conditions of this part are met

The document or corridor of a document to be submitted have been linked in public programNo. 92S-0251 as being the type of submission the agency accepts in electronic form. This program will identify specifically what types of documents or corridor of documents are respectable for submission in electronic form without paper records and the agency entering unit (s) (e.g., specific center, office, division, branch) to which similar cessions may be made.

Documents to agency entering unit (s) not specified in the public program won’t be considered as functionary if they’re submitted in electronic form; paper forms of similar documents will be considered as sanctioned and must accompany any electronic records. Persons are anticipated to consult with the intended agency entering unit for details on how (e.g., system of transmission, media, train formats, and specialized protocols) and whether to do with the electronic submission.

§11.3 Delineations:

The delineations and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.

The ensuing delineations of terms also apply to this part

Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21U.S.C. 321-393)).

Agency means the Food and Drug Administration.

Biometrics means a system of vindicating an existent’s identity grounded on dimension of the existent’s physical point (s) or unremarkable action (s) where those features and/ or conduct are both unique to that individual and measurable.

Closed system means an terrain in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Digital hand means an electronic hand grounded upon cryptographic styles of originator authentication, reckoned by using a set of rules and a set of parameters similar that the identity of the signer and the integrity of the data can be vindicated.

Electronic record means any combination of textbook, plates, data, audio, pictorial, or other information representation in digital form that’s created, modified, maintained, archived, recaptured, or distributed by a computer system.

Electronic hand means a computer data compendium of any symbol or series of symbols executed, espoused, or authorized by an individual to be the fairly binding fellow of the existent’s handwritten hand.

Handwritten hand means the scripted name or legal mark of an individual handwritten by that individual and executed or espoused with the present intention to authenticate a jotting in a endless form. The act of subscribing with a jotting or marking instrument similar as a pen or stylus is saved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other bias that capture the name or mark.

Open system means an terrain in which system access isn’t controlled by persons who are responsible for the content of electronic records that are on the system.

§11.10 Controls for unrestricted systems:

Persons who use unrestricted systems to produce, modify, maintain, or transmit electronic records shall employ procedures and controls designed to insure the authenticity, integrity, and, when applicable, the confidentiality of electronic records, and to insure that the signer can not readily repudiate the inked record as not genuine. Similar procedures and controls shall include the following

Confirmation of systems to insure delicacy, trustability, harmonious intended performance, and the capability to discern invalid or altered records.

The capability to induce accurate and complete clones of records in both mortal readable and electronic form suitable for examination, review, and copying by the agency. Persons should communicate the agency if there are any questions regarding the capability of the agency to perform similar review and copying of the electronic records.

Protection of records to enable their accurate and ready reclamation throughout the records retention period.

Limiting system access to authorized individualities.

Use of secure, computer-generated, time- stamped inspection trails to singly record the date and time of driver entries and conduct that produce, modify, or cancel electronic records. Record changes shall not obscure preliminarily recorded information. Similar inspection trail attestation shall be retained for a period at least as long as that needed for the subject electronic records and shall be available for agency review and copying.

Use of functional system checks to apply permitted sequencing of way and events, as applicable.

Use of authority checks to insure that only authorized individualities can use the system, electronically subscribe a record, access the operation or computer system input or affair device, alter a record, or perform the operation at hand.

Use of device (e.g., terminal) checks to determine, as applicable, the validity of the source of data input or functional instruction.

Determination that persons who develop, maintain, or use electronic record/ electronic hand systems have the education, training, and experience to perform their assigned tasks.

The establishment of, and adherence to, written programs that hold individualities responsible and responsible for conduct initiated under their electronic autographs, in order to discourage record and hand falsification.

Use of applicable controls over systems attestation including

Acceptable controls over the distribution of, access to, and use of attestation for system operation and conservation.

Modification and change control procedures to maintain an inspection trail that documents time-sequenced development and revision of systems attestation.

§11.30 Controls for open systems:

Persons who use open systems to produce, modify, maintain, or transmit electronic records shall employ procedures and controls designed to insure the authenticity, integrity, and, as applicable, the confidentiality of electronic records from the point of their creation to the point of their damage.

Similar procedures and controls shall include those linked in§11.10, as applicable, and fresh measures similar as document encryption and use of applicable digital hand norms to insure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.

11.50 Hand instantiations:

Inked electronic records shall contain information associated with the signing that easily indicates all of the following

The published name of the signer;

The date and time when the hand was executed; and

The meaning ( similar as review, blessing, responsibility, or authorship) associated with the hand.

The particulars linked in paragraphs (a) (1), (a) (2), and (a) (3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any mortal readable form of the electronic record ( similar as electronic display or printout).

§11.70 Hand/ record linking:

Electronic autographs and handwritten autographs executed to electronic records shall be linked to their separate electronic records to insure that the autographs can not be gutted, copied, or else transferred to falsify an electronic record by ordinary means.

11.100 General conditions:

Each electronic hand shall be unique to one existent and shall not be reused by, or reassigned to, anyone differently.

Before an association establishes, assigns, certifies, or else warrants an existent’s electronic hand, or any element of similar electronic hand, the association shall corroborate the identity of the existent.

Persons using electronic autographs shall, previous to or at the time of similar use, certify to the agency that the electronic autographs in their system, used on or after August 20, 1997, are intended to be the fairly binding fellow of traditional handwritten autographs.

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