Validation is an integral process in every successful quality organization, ensuring products meet both the requirements of the customer, as well as any applicable regulatory requirements. The validation process provides assurance that a company’s processes are operating effectively and builds confidence in the quality of the end-product to establish brand loyalty with customers.

However, the common perception of the software validation is that it is complex, expensive, time-consuming and inefficient. This brief is intended to share knowledge gleaned from hundreds of AssurX customer implementations to dispel common misconceptions about software validation.

Common myths addressed include:

• Validation costs and complexity
• When software validation is required
• Types of functionality that require validation
• Utilization of PQ for adequate documentation

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