[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.60]
[Page 111]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 203 PRESCRIPTION DRUG MARKETING--Table of Contents
Subpart F Request and Receipt Forms, Reports, and Records
Sec. 203.60 Request and receipt forms, reports, and records.
(a) Use of electronic records, electronic signatures, and
handwritten signatures executed to electronic records. (1) Provided the
requirements of part 11 of this chapter are met, electronic records,
electronic signatures, and handwritten signatures executed to electronic
records may be used as an alternative to paper records and handwritten
signatures executed on paper to meet any of the record and signature
requirements of PDMA, PDA, or this part.
(2) Combinations of paper records and electronic records, electronic
records and handwritten signatures executed on paper, or paper records
and electronic signatures or handwritten signatures executed to
electronic records, may be used to meet any of the record and signature
requirements of PDMA, PDA, or this part, provided that:
(i) The requirements of part 11 of this chapter are met for the
electronic records, electronic signatures, or handwritten signatures
executed to electronic records; and
(ii) A reasonably secure link between the paper-based and electronic
components exists such that the combined records and signatures are
trustworthy and reliable, and to ensure that the signer cannot readily
repudiate the signed records as not genuine.
(3) For the purposes of this paragraph (a), the phrase ``record and
signature requirements of PDMA, PDA, or this part'' includes drug sample
request and receipt forms, reports, records, and other documents, and
their associated signatures required by PDMA, PDA, and this part.
(b) Maintenance of request and receipt forms, reports, records, and
other documents created on paper. Request and receipt forms, reports,
records, and other documents created on paper may be maintained on paper
or by photographic imaging (i.e., photocopies or microfiche), provided
that the security and authentication requirements described in paragraph
(c) of this section are followed. Where a required document is created
on paper and electronically scanned into a computer, the resulting
record is an electronic record that must meet the requirements of part
11 of this chapter.
(c) Security and authentication requirements for request and receipt
forms, reports, records, and other documents created on paper. A request
or receipt form, report, record, or other document, and any signature
appearing thereon, that is created on paper and that is maintained by
photographic imaging, or transmitted electronically (i.e., by facsimile)
shall be maintained or transmitted in a form that provides reasonable
assurance of being:
(1) Resistant to tampering, revision, modification, fraud,
unauthorized use, or alteration;
(2) Preserved in accessible and retrievable fashion; and
(3) Available to permit copying for purposes of review, analysis,
verification, authentication, and reproduction by the person who
executed the form or created the record, by the manufacturer or
distributor, and by authorized personnel of FDA and other regulatory and
law enforcement agencies.
(d) Retention of request and receipt forms, reports, lists, records,
and other documents. Any person required to create or maintain reports,
lists, or other records under PDMA, PDA, or this part, including records
relating to the distribution of drug samples, shall retain them for at
least 3 years after the date of their creation.
(e) Availability of request and receipt forms, reports, lists, and
records. Any person required to create or maintain request and receipt
forms, reports, lists, or other records under PDMA, PDA, or this part
shall make them available, upon request, in a form that permits copying
or other means of duplication, to FDA or other Federal, State, or local
regulatory and law enforcement officials for review and reproduction.
The records shall be made available within 2 business days of a request.
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