Validation of computerized analytical systems, part I: Overview, regulations, and terminology

LC GC Europe

Volumn 9, Issue 9, 1996, Pages 564-572

  Huber, Ludwig ^a  

^a Hewlett Packard GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0010577065     PISSN: 14716577     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. US Food and Drug Administration, Guidelines, Recommendations and Agreements, 43 FR 45076 (Part 210) and 43 FR 45077 (Part 211) (Government Printing Office, Washington, D.C., USA, 29 September 1978).
2. The Application of the Principles of GLP to Computerized Systems, Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 10, GLP Consensus Document, Environment Monograph No. 116 (Organization for Economic Cooperation and Development, Paris, France, 1995).
3. Compliance of Laboratory Suppliers with GLP Principles, Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 5, GLP Consensus Document, Environment Monograph No. 49 (Organization for Economic Cooperation and Development, Paris, France, 1992).
4. EC Guide to Good Manufacturing Practice for Medicinal Products in the Rules Governing Medicinal Products in the European Community, vol. IV (Commission of the European Communities, Office for Official Publications for the European Communities, Luxembourg, 1992).
5. Good Clinical Practice for Trials on Medicinal Products in the European Community (European Communities Clinical Practice for Medicinal Products, Commission of the European Communities, Brussels, Belgium, 1991), p. 23.
6. US Environmental Protection Agency, Good Automated Laboratory Practices, Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations (Office of Information Resources Management, Research Triangle Park, North Carolina, USA, 10 August 1995).
7. General Criteria for the Operation of Testing Laboratories, EN 45001 (CEN/CENELEC, The Joint European Standard Institution, Brussels, Belgium, 1989).
8. General Requirements for the Competence of Calibration and Testing Laboratories (International Organization for Standardization, Geneva, Switzerland, 3rd ed., 1990).
9. EURACHEM Guidance Document No. 1, WELAC Guidance Document No. WGD 2: Accreditation for Chemical Laboratories: Guidance on the Interpretation of the EN 45000 Series of Standards and ISO-IEC Guide 25 (EURACHEM, Teddington, UK, 1993).
10. Pharmaceutical Manufacturer's Association Computer System Validation Committee, Pharm. Technol. 10(5), 24-34 (1986).
11. L. Huber, Validation of Computerized Analytical Systems (Interpharm, Buffalo Grove, Illinois, USA, 1995).
12. US FDA, Guidelines on General Principles of Validation (Center for Drug Evaluation and Research, Rockville, Maryland, USA, 15 May 1987).
13. Quality Management and Quality Assurance Standards, Part 3: Guidelines for the Application of ISO 9001 to the Development, Supply and Maintenance, ISO 9000-3 (International Organization for Standardization, Geneva, Switzerland, 1991).