ARTICLE;
CERTIFICATION;
CLINICAL LABORATORY;
COMPUTER PROGRAM;
FOOD AND DRUG ADMINISTRATION;
GOOD LABORATORY PRACTICE;
INFORMATION SYSTEM;
LABORATORY AUTOMATION;
MEDICAL AUDIT;
MEDICAL DOCUMENTATION;
PRACTICE GUIDELINE;
QUALITY CONTROL;
VALIDATION PROCESS;
CLINICAL LABORATORY INFORMATION SYSTEMS;
COMPUTERS;
EVALUATION STUDIES;
HUMANS;
QUALITY ASSURANCE, HEALTH CARE;
SOFTWARE;
Regulation of clinical laboratory information systems after the 1990 amendments to the Food and Drug Act
Brannigan VM. Regulation of clinical laboratory information systems after the 1990 amendments to the Food and Drug Act. Clin Lab Management Rev. 1992;6:49-57.
Implementing a regulation-compliant quality improvement program on a commercial information system
Cowan DF. Implementing a regulation-compliant quality improvement program on a commercial information system. Anal Quant Cytol Histol. 1992; 14:407-414.
International Organization for Standardization, 1, rule de Varembé, Case postale 56, CH-1211, Genève 20, Switzerland
International Organization for Standardization, 1, rule de Varembé, Case postale 56, CH-1211, Genève 20, Switzerland.
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2242462981
Rockville, Md: US Food and Drug Administration, Center for Biologics Evaluation and Research; Docket no. 93N-0394
Draft Guideline for the Validation of Blood Establishment Computer Systems. Rockville, Md: US Food and Drug Administration, Center for Biologics Evaluation and Research; 1993. Docket no. 93N-0394.
Rockville, Md: US Food and Drug Administration, Center for Drugs and Biologics and Center for Devices and Radiological Health
Guideline on General Principles of Process Validation. Rockville, Md: US Food and Drug Administration, Center for Drugs and Biologics and Center for Devices and Radiological Health; 1987.
