[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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.
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