[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR11.10]



[Page 111-112]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 11_ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents

 

                      Subpart B_Electronic Records

 

Sec.  11.10  Controls for closed systems.





    Persons who use closed systems to create, modify, maintain, or 

transmit electronic records shall employ procedures and controls 

designed to ensure the authenticity, integrity, and, when appropriate, 

the confidentiality of electronic records, and to ensure that the signer 

cannot readily repudiate the



[[Page 112]]



signed record as not genuine. Such procedures and controls shall include 

the following:

    (a) Validation of systems to ensure accuracy, reliability, 

consistent intended performance, and the ability to discern invalid or 

altered records.

    (b) The ability to generate accurate and complete copies of records 

in both human readable and electronic form suitable for inspection, 

review, and copying by the agency. Persons should contact the agency if 

there are any questions regarding the ability of the agency to perform 

such review and copying of the electronic records.

    (c) Protection of records to enable their accurate and ready 

retrieval throughout the records retention period.

    (d) Limiting system access to authorized individuals.

    (e) Use of secure, computer-generated, time-stamped audit trails to 

independently record the date and time of operator entries and actions 

that create, modify, or delete electronic records. Record changes shall 

not obscure previously recorded information. Such audit trail 

documentation shall be retained for a period at least as long as that 

required for the subject electronic records and shall be available for 

agency review and copying.

    (f) Use of operational system checks to enforce permitted sequencing 

of steps and events, as appropriate.

    (g) Use of authority checks to ensure that only authorized 

individuals can use the system, electronically sign a record, access the 

operation or computer system input or output device, alter a record, or 

perform the operation at hand.

    (h) Use of device (e.g., terminal) checks to determine, as 

appropriate, the validity of the source of data input or operational 

instruction.

    (i) Determination that persons who develop, maintain, or use 

electronic record/electronic signature systems have the education, 

training, and experience to perform their assigned tasks.

    (j) The establishment of, and adherence to, written policies that 

hold individuals accountable and responsible for actions initiated under 

their electronic signatures, in order to deter record and signature 

falsification.

    (k) Use of appropriate controls over systems documentation 

including:

    (1) Adequate controls over the distribution of, access to, and use 

of documentation for system operation and maintenance.

    (2) Revision and change control procedures to maintain an audit 

trail that documents time-sequenced development and modification of 

systems documentation.