Specifications Inspection and testing

To meet this requirement for documented procedures you will need two types of procedure procedures which provide for the necessary inspections and tests to be planned and carried out at the appropriate stage of the process and procedures for carrying out the specific inspections and tests. However, this is not to say that you need to document how you conduct every type of inspection or test. You only need procedures which define how inspections and tests are to be performed when the lack of them will adversely affect the result. Where the inspection and test methods are no more than using the tools of the trade, no procedures will be necessary providing the acceptance criteria are specified in a specification, drawing, or other such document. 

The development model contains specific inspection and testing tasks that are appropriate for the intended use of the computer system. 

Operational checks are normally presenting process control computer systems. These systems may contain code that is part of the master production record. At the system level, the purpose of operational checks is to execute algorithms, sequencing of operations, and safety-related functions as required in the applicable customer specification. Inspections and testing are fundamental processes to be performed during the validation of critical system sequences. In addition, an ongoing program must be established to frequently verify that critical operations occur in the proper sequence. 

The development methodology associated with the SLC is a structured process that decomposes the engineering tasks and associated work products in support of the computer system validation effort. It breaks down the systems development process into subperiods, containing specific inspection and testing tasks that are appropriate for the intended use of the computer system. During each subperiod, detailed discrete work products are developed. This approach leads to well-documented systems that are easier to test and maintain, and for which an organization can have confidence that the system s functions will be fulfilled with a minimum of unforeseen problems. 

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