Software Validation Overview

The IQS Validation Practice has provided software validation services to companies in closely regulated industries including pharmaceuticals and medical devices. IQS has years of experience in such industries and can mentor every customer's personnel in software validation (guided approach), or the IQS validation team can perform the validation itself if a customer lacks sufficient time or resources (turnkey approach).

Objectives of the Validation: 

• To achieve the regulatory requirements for Software Validation and Quality System regulation
• To document and justify risk assessment methodology
• Provide customer's personnel with knowledge and expertise to allow future incremental Software Validations to be performed

IQS can perform validation not only on its own systems, but the broad background, and proven methodology of its services team allow it to perform software validation on any software package.