[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.270]

[Page 736]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.270  Records.

    (a) General. You must maintain records concurrently with the 
performance of each step required in this subpart and subpart C of this 
part. Any requirement in this part that an action be documented involves 
the creation of a record, which is subject to the requirements of this 
section. All records must be accurate, indelible, and legible. The 
records must identify the person performing the work and the dates of 
the various entries, and must be as detailed as necessary to provide a 
complete history of the work performed and to relate the records to the 
particular HCT/P involved.
    (b) Records management system. You must establish and maintain a 
records management system relating to core CGTP requirements. Under this 
system, records pertaining to a particular HCT/P must be maintained in 
such a way as to facilitate review of the HCT/Ps history before making 
it available for distribution and, if necessary, subsequent to the HCT/
Ps release as part of a followup evaluation or investigation. Records 
pertinent to the manufacture of HCT/Ps (e.g., labeling and packaging 
procedures, and equipment logs) must also be maintained and organized 
under the records management system. If records are maintained in more 
than one location, then the records management system must be designed 
to ensure prompt identification, location, and retrieval of all records.
    (c) Methods of retention. You may maintain records required under 
this subpart electronically, as original paper records, or as true 
copies such as photocopies, microfiche, or microfilm. Equipment that is 
necessary to make the records available and legible, such as computer 
and reader equipment, must be readily available. Records stored in 
electronic systems must be backed up.
    (d) Length of retention. You must retain all records for 10 years 
after their creation, unless stated otherwise in this part. However, you 
must retain the records pertaining to a particular HCT/P at least 10 
years after the date of its administration, or if the date of 
administration is not known, then at least 10 years after the date of 
the HCT/Ps distribution, disposition, or expiration, whichever is 
latest. You must retain records for archived specimens of dura mater for 
10 years after the appropriate disposition of the specimens.
    (e) Contracts and agreements. You must maintain the name and address 
and a list of the responsibilities of any establishment that performs a 
manufacturing step for you. This information must be available during an 
inspection conducted under Sec. 1271.400.