What Is Needed to Support Validated Systems

Each organization should define its policy on computer validation and make sure it is implemented and followed. For regulatory and business purposes, all computer-related systems must be validated which 

Management may also decide that additional systems should be validated to ensure the accuracy and reliability of data for business reasons. 

An inventory should be made of all systems. The inventory should indicate whether each system falls within any of the above categoies and if it needs to be validated at all. 

The GAMP classification [l](see Appendix 13.2 to this chapter) gives guidance on the possible ways to reduce validation efforts based on risk assessment and the type of system. Another aspect to take into account is the potential risk associated with system failure. In case of low potential risk, validation efforts could be reduced. 

The GxP aiticality of each module or function within a system should be examined. If they are well defined and documented, the validation efforts could focus mainly on the most critical functions. 

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