EAM Validation Strategy

Earlier discussions have referred to systems in terms of mechanical assets. The following discussion refers to the systems in terms of the information systems supporting the EAM strategy. 

The cost of validation is much publicized as is the debate regarding the extent to which information systems should be validated. Validation is essentially the term adopted by the pharmaceutical industry and its regulators to define the additional rigor required to confirm GxP-critical aspects of information systems throughout the development and operational life of those systems. Given that pharmaceutical regulators have the power to withhold, suspend or withdraw product licenses, it essential that pharmaceutical enterprises validate GxP-critical functions. In order to maximize business efficiency and minimize cost, it is also essential that pharmaceutical enterprises differentiate those functions of the information systems that are GxP critical and those that are not and, hence, focus valuable and limited resources where they are most warranted. 

Processes used to determine functional criticality, such as FMEA, have already been discussed within this chapter. Similarly, FMEA and other risk assessment tools can be used to determine the scope of validation. The risk of failure increases as information systems supporting the EAM strategy deviate from a standardized solution, that is, the level of tailored development increases. In addition, the extent to which a product is utilized within an industry, in particular pharmaceuticals, must be taken into consideration when determining the scope of validation. 

The pharmaceutical organization must develop a Validation Master Plan (VMP) to define the validation strategy for the implementation of the IS architecture. The VMP should address the process by which the pharmaceutical organization assures the quality of the products being procured and the strategy for validating the specific implementation of those products. 

Regulators consider the VMP to be the first fundamental commitment of the pharmaceutical enterprise to the validation process. In particular, the VMP must recognize that different approaches may be required to meet the 

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