Full development data management

Internal summary reports and formal proposals for management are often assembled in preparation for development milestones (e.g., candidate selection and full development decision). Research reports for critical data are written for products as they progress through development. However, reports for failing studies or discontinued programs are often not prepared and these can be equally useful since history tends to repeat itself. Because of the time and resources required to prepare such reports, a conscious decision should be made if the value added warrants the effort. 

Most of the instruments used in the laboratory are commercial off-the-shelf (COTS) instruments, and consequently the users have little or no input into their design. A full system development life-cycle (SDLC) approach [8], which is used to develop complex computerized systems such as Laboratory Information Management System (LIMS) or Chromatographic Data System (CDS) or custom design laboratory equipment, is not appropriate for COTS instruments. Some laboratory instruments such as a pH meter or centrifuge are fairly simple and therefore do not warrant the SDLC approach. 

The general process of sample transformation into data is the same at every environmental laboratory. The differences are primarily in the manner various tasks are performed by laboratory personnel. To assure the quality of produced data, every laboratory must develop, implement, and maintain a quality system that is documented in the Laboratory QA Manual. The implementation of specific tasks related to sample management, analysis, and quality system, which may be different at different laboratories, is addressed through a set of laboratory s own SOPs. A full service laboratory has dozens of SOPs, describing every laboratory procedure and task from sample receiving to invoicing. The SOPs are updated as necessary and undergo internal review and approval. 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

Robotic NMR Assays. Spectra were collected on a Varian VXR300S spectrometer equipped with a Varian automatic sample management system (robot) with a 50 sample tray using the parameters described above. Customized software was developed for robot control providing full automated work-up of data including the calculation of weight percents and generation of analytical reports. 

The diagnostic tool developed by Foggin et al. (2004) is easy to handle and is structured to be completed within an hour. It solely involves data that can be easily obtained. The method is thereby qualitative in nature. The supply chain diagnostic tool is a questionnaire that helps to quickly identify problems and diagnose the current problems existing in a potential customer s supply chain. The following overview (Fig. 1.6) shows an approach to the areas of interest to identily key issues within inventory management. It is thereby only an abstract of the full... 

---