Software Validation Overview
The IQS Validation Practice can provide validation services to companies in closely regulated industries including pharmaceuticals, biotechnology and medical devices. The experience of the validation team covers biological and chemical processes, equipment, automation, facilities, software and laboratories. Utilizing strengths in engineering, science and GMP compliance, our validation services provide practical, efficient and innovative approaches to technical challenges that meet the FDA's high standards of quality. With a culture dedicated to outstanding performance and customer service, we are driven to deliver exceptional value to our clients by helping them meet their business goals across the operational enterprise.
Objectives of the Validation:
- To achieve the regulatory requirements for Process / Software / Equipment Validation and Quality System regulation.
- To document and justify, using a risk assessment methodology, the validation process.
- Provide the customer, where required, with knowledge and expertise to allow future Validations to be performed internally.
Validation Services are not limited to the IQS software system. The broad background and proven methodology of the validation services team allow us to perform validation across the spectrum of validation requirements for Medical Devices, Pharmaceuticals, Biotechnology products and other regulated industries.