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Consideration should be given to the risk of losing aspects of the previous system by reducing the involvement of operators. It is essential that there is the closest co-operation between key personnel and those involved with computer systems.

Persons in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility which utilises computers.

In recent years pharmaceutical industry focus much more on validation of computer system, but big question is that which systems do we have to validate? Answer of the question may be simple but it is difficult to carry out.

validatingcomputerizedsystem com-84

It should describe the principles, objectives, security measures and scope of the system and the main features of the way in which the computer is used and how it interacts with other systems and procedures. The software is a critical component of a computerised system.The user of such software should take all reasonable steps to ensure that it has been produced in accordance with a system of Quality Assurance. Before a system using a computer is brought into use, it should be thoroughly tested and confirmed as being capable of achieving the desired results.If a manual system is being replaced, the two should be run in parallel for a time, as part of this testing and validation. Data should only be entered or amended by persons authorised to do so.Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities.In this business it is of outstanding importance to generate valid data for the assessment of drug development candidates to assure that the huge financial investment, which is based on such assessments, can be successful.




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