Personal Computer Software Management

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Modern laboratories are complex multifaceted units with vast amounts of information passing to and from instruments and computers and to and from analysts and clients daily. The development of highspeed, high-performance computers has provided laboratory personnel with the means to handle the situation with relative ease. Software written for this purpose has meant that ordinary personal computers can handle the chores. The hardware and software system required has come to be known as the laboratory information management system (LIMS). 

Unfortunately, it is this writer s opinion that, considering the voluminous publications on chemometrics applications, the number of actual effective process analytical chemometrics applications in the field is much less than expected. Part of this is due to the overselling of chemometrics during its boom period, when personal computers (PCs) made these tools available to anyone who could purchase the software, even those who did not understand the methods. This resulted in misuse, failed applications, and a bad taste with many project managers (who tend to have long memories...). Part of the problem might also be due to the lack of adequate software tools to develop and safely implement chemometric models in a process analytical environment. Finally, some of the shortfall might simply be due to lack of qualified resources to develop and maintain chemometrics-based analytical methods in the field. 

Computer software Developing technology Freestyle CoPilot Working on communications with a pump Carelink Personal Software Closed-loop sensor and pump in clinical trials (Yale, elsewhere) Carelink Personal Software DexCom DM Consumer Data Manager ( 79) Long-term (about 1 year/outpatient procedure) implantable sensor... 

Parallel to the rise in commercial LIMS, the processing speed of third-party software capabilities increased and laboratories switched more and more to small workstations and personal computers, and the LIMS environment had to follow this trend. During the 1990s, the term LIMS became universally recognized, and more and more standard solutions from commercial software vendors became available. The systems were refined to combine the individual transfer of laboratory test data into the transfer and consolidation of the results to provide laboratory managers an overall view of the laboratory and a platform to assist them in running the laboratory. 

These basic modules provide the foimdation for an effective maintenance management system. Many other system functions are offered, depending on the CMMS sophistication and intended application. CMMS software packages are now being sold by more than 300 vendors for applications on personal computers, minicomputers, and mainframes. 

OS operating system, PC personal computer, LDAP lightweight directory access protocol, CMS content management systems, SIS software installation script... 

CBT systems support a wide range of delivery media, including personal computers, laptops, tablets, and smart phones. The products work in computer systems and Internet-based systems. Presentation software manages lesson presentations. Presentation software can also time and score smdent progress and record completion of each lesson to help manage training. 

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