InfoQuest provides validation consultancy for organizations seeking regulatory compliance on computerized systems. Our team has hands-on experience of working to regulatory requirements throughout the development lifecycle. We have the regulatory knowledge and real-world experience to enable organizations to successfully follow through on compliance initiatives.

We have experienced consultants trained in FDA regulations and related industry regulations and guidelines. Our consultants have experience in the pharmaceutical industry to achieve quality and compliance with their systems.

• Standard Operating Procedure (SOP) Development
• Full life cycle Computer System Validation
• Risk assessment
• Quality Assurance Management
• Validation Master Plan and Project Management
• Design and development of Validation procedures
• 21 CFR Part 11 assessments
• 21 CFR Part 11 implementation
• 21 CFR Part 11 training
• current Good Manufacturing Practice (cGMP) compliance
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)
• Validation summary