By J. E. H. Stafford (auth.), Dr J. E. H. Stafford (eds.)

Laboratory details Managements structures (LIMS) are both custom-built or off-the-shelf options to the issues of controlling the stream of information via laboratories. during this e-book advertisement relevance is ensured by way of authors from significant business companies who display by way of instance winning program of the know-how. This e-book presents a great up to date evaluate of this intensely aggressive field.

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1992) Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm. , 9 (4), 588-592 16. Rogalski, W. (1994) Global electronic submissions, part I: The DAMOS transfer interface standard. Applied Clinical Trials, 3 (11), 30-40. 17. P. ) (1992) CANDA: A Regulatory, Technology and Strategy Report. Parexal In!. , Waltham, MA, USA. 18. Rank, M. (1993) Automating procedure management for regulated industries through LIMS. , 6 (6), 342-344. 19. A. (1993) FDA Perspective on CANDAs.

The ability to demonstrate chain of custody of an analytical sample is a key element where data might be subjected to judicial scrutiny. However, to enable a full history of the sample to be known the laboratory system requires foreknowledge of the sample's existence. Thus there is increasing interest in being able to manage and monitor the collection of samples, their storage and transfer to the analytical laboratory. LIMS that informate have the ability to predict sampling requirements. However, since the context of the sample must also be known, the simple sample login schedulers characteristic of many current LIMS are not adequate.

5 A LIMS model The model consists of two principles that form the basis of an architecture for a comprehensive LIMS: • First, a LIMS is divided into a set of functional components. This means that the boundaries and scope of each of these functional areas are clearly understood . • Second, the interaction between these functional areas is defined by a common method that allows each area to grow and expand independently of any other, thus preserving a path for incremental growth, upward compatibility and future expansion of the model itself.

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