Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation.

Format:

Book

Government document

Contributor:

United States. Food and Drug Administration. Office of Regulatory Affairs

Center for Biologics Evaluation and Research (U.S.)

Center for Drug Evaluation and Research (U.S.)

Center for Devices and Radiological Health (U.S.)

Center for Food Safety and Applied Nutrition (U.S.)

Center for Veterinary Medicine (U.S.)

Language:

English

Subjects (All):

Electronic records--Government policy--United States.

Electronic records.

United States.

Physical Description:

1 online resource (iii, 21 pages)

Other Title:

21 CFR part 11, electronic records

Electronic signatures, validation

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001]

Notes:

Title from PDF title page (viewed on July 27, 2009).

"Draft guidance."

"August 2001."

Includes bibliographical references (pages 15-21).

OCLC:

427904766