Computerized system definition

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

This definition embraces all uses of computer systems and has been widely adopted, albeit with modifications, by the various GxP regulatory authorities around the world. These are sometimes dubbed computerized systems. The creation of validatable software is, in the first instance, largely a matter of the software developer adopting the basic principles of good software engineering practices under formal documented quality assurance supervision. 

The validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

Equipment (also referred to as instrument or system) Analytical measurement or processing hardware including firmware (Section 6.1). In some cases, a reference to equipment may actually refer to an integrated system that is comprised of two or more instruments. In a computerized system the equipment may be controlled by the computer system (instrument work station). The instrument work station may also collect measurement data from the equipment and be included as part of the overall system definition. 

The Air Force determined that the model needed to be computerized to be maximally useful. They initially considered using dBase or Lotus software for implementing the model, but then decided that expert systems technology could provide some definite advantages such as the ability to ... 

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