Computerized Maintenance Management Software

Computerized Maintenance Management Software (CMMS) Administration... 

Analyzers database implementation Normally the data provided by the computerized maintenance management systems (CMMS) are not sufficient to provide the information needed to make the right decisions regarding improving analyzers reliability. The combination of the CMMS and an analyzer database provides a very powerful tool. Today, there are several commercial instrument database software available in the market. Alternatively, an analyzer database can be developed in-house using common database software such as Microsoft Access. An analyzer database should contain the following basic information ... 

Basically, CMMS/EAM provides computer software programs designed to assist in the planning, management, and administrative procedures required for an effective maintenance process. The need for a maintenance management system, whether manual or computerized, is determined by the need to perform effective maintenance on assets, equipment and facilities. We can think of CMMS/EAM as providing the business system for maintenance operations. 

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... 

All regulatory agencies adopt what amounts to a life cycle approach to developmental and operational control of computerized equipment, with emphasis on documentation of software development and quahty management especially in GLP environments. The life cycle for analytical instruments from the user s perspective includes the purchasing phase (including system/vendor qualification), the IQ, OQ and PQ phases of AIQ (Section 9.5.1a), the maintenance phase and, fmaEy, the retirement phase, which probably occurs more frequently with respect to computers and software than the analytical instruments... 

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