ISPE 4VLCS

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GAMP Good Practice Guide: Validation of Laboratory Computerized SystemsInternational Society for Pharmaceutical Engineering / 2005 / 96 pages ISBN: 1931879397

The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems provides a harmonized overview of the key elements involved in the life cycle of laboratory computerized systems, from initiation to retirement. The focus of the Guide is on computerized laboratory instrumentation, data management, and analysis systems. It is intended as a supplement to The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture - GAMP4.
The scope of this guidance includes laboratory computer systems used within the regulated healthcare industries subject to good manufacturing practice (GMP), good laboratory practice (GLP), or good clinical practice (GCP).
This GAMP Good Practice Guide describes systems categorization and risk assessment processes which can be used to determine a rational, scalable approach to the validation of laboratory computerized systems, by building upon the GAMP 4 software categories.
This Guide aims to provide guidance to address strategic and tactical computer system validation issues of current interest to validation practitioners, including:
- Examination of the traditional system development life cycle (SDLC) and its applicability for most laboratory computerized systems
- Identification of characteristics that distinguish various laboratory computerized systems
- Development of a rationale for scaling the effort associated with the validation of laboratory computerized systems
- Development of a strategy for supplier assessment to supplement company specific validation activities
- Further definition of the GAMP 4 Guide for Validation of Automated Systems risk assessment approach to make it more applicable to laboratory computerized systems
- Definition of necessary controls to maintain laboratory computerized systems in a validated state
- Recommendation on activities to be performed when a laboratory computerized system is no longer suitable for its intended use
The intended audience for this GAMP Good Practice Guide includes laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries. Information technology (IT) personnel supporting these systems, management, and laboratory computerized systems users, software developers, and suppliers of laboratory computerized systems are also expected to benefit from using this Guide.




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