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Abstract:
The proposed Subpart P regulations are well-intended, but in many instances fail to take into account the capabilities of present state-of-the-art laboratory information systems and, in effect, may result in increased cost. This may preclude many laboratories from taking advantage of today's available technologies and systems. However, a number of the regulations are reasonable and non-aversive, and in fact reflect what is presently occurring in most well-managed computerized laboratories. CIOs and MIS directors may be interested in the ASTM (American Society for Testing and Materials) 1990 Annual Book of ASTM Standards, which includes several useful standards pertaining to computerized laboratory systems.