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 and through the use of a risk-managed approach to validation, we are driven to deliver exceptional value to our clients by helping them meet their business goals across the operational enterprise.

The US FDA and international regulators have increased enforcement of computer system validation.

• Both 21 CFR Part 820 and ISO 13485, specifically Section 820.70 and Section 7.5.2, require critical computer systems to be validated        
• The United States Congress continues to pressure the US FDA to improve its operations, strengthen its inspections and hire more experts and as a result, US FDA has increased its staff by over 7.5%, to step up inspections and address increases in consumer safety concerns.
• Over 77% of the warning letters issued by the US FDA in 2008 and 2009 included process or software validation deficiencies, a 280% increase over the previous 6 years.
• Rapid improvements in computer technologies have made Part 11 compliance a top priority at the FDA.

With additional services and training options available, IQS is ideally positioned to provide you and your organization the tools and skills you need to compete in your regulated industry.