Validatingcomputerizedsystem com radio forth dating
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.It may have been a fluid document and evolved during the “build”, but at some point you have said that’s it, this is what the final specification is. At this particular organisation this was not the case, only draft versions of both the user requirements and functional specifications were provided.So at the starting point of attempting to assess whether the system was in a validated state, it was not possible to identify all the user requirements and functionality that were included in the build and therefore confirm that these had been validated.This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and changing. A written detailed description of the system should be produced (including diagrams as appropriate) and kept up to date.
I’m not going to go through the whole product development life cycle and I appreciate with new Agile and Sprint development methodology processes are changing, but at some point you will have a finalised specification document.
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.