The cost and time associated with validation of GxP computerized systems can represent a significant part of the overall software implementation budget.
For many years, life science companies have been burdened with the cumbersome process of validation, often taking as long as the implementations themselves.
Regulatory agencies have recognized this and recommend a risk-based approach to focus validation efforts on high-risk areas and reduce the validation burden whilst improving quality. This approach is at the core of Montrium’s validation service offering.
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