Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment.
In summary, the validation of purchased software and add-on programs requires careful examination of the situation to determine the most effective and logical methods. A standard validation methodology that is used for larger systems would be difficult and possibly dangerous to employ for a PC system because of the significant differences between the environments. It should be noted, however, that there are almost daily changes in the computer software industry. A number of potential solutions have emerged over the past few years that can be applied to reduce the concerns caused by the apparently insufficient controls in the PC environment. For example, currently available technologies would permit multiple PC users to access a secure central application or repository of data and prevent them from making changes to a validated system or database. A properly designed system could enable these distributed users to use the data to perform their required functions, while maintaining a validated state.
Nitahara
K
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META Solutions, Inc., Warren, New Jersey 07059.
D002984:Clinical Laboratory Information Systems / Q000592:standards*; D003199:Computer Systems / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D008838:Microcomputers / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012986:Software Validation