IQ/OQ/PQ Validation

Have you recently moved or installed new equipment?
Do you need protocols written?
Want to ensure cGMP-compliance?

Think Integrated Service Solutions, Inc. With ISO 9001:2000 registration and ISO/IEC 17025:2005 accreditation, we have a team of validation experts and comprehensive knowledge of FDA validation requirements. Well-versed in the specific requirements of pharmaceutical and biotechnology compliance, Integrated Service Solutions personnel are completely knowledgeable with pharmaceutical processes. We supply full cGMP documentation packages and periodic re-qualification to meet strict FDA standards. Our experienced validation team will write clear, concise documents and implement IQ/OQ/ PQ protocols for all brand name manufacturers as well as specialized equipment qualifications to ensure compliance requirements.

All of our validation services are thoroughly documented with detailed graphs and charts and are methodically reviewed by our quality assurance department before being released to the customer.

We support all areas of life science companies including manufacturing, packaging, facilities engineering, maintenance, microbiology, analytical research and development and quality control. Our complete turnkey services include:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Summary Reports
• Standard Operating Procedures (SOP)
• GAP Analysis
• Temperature Mapping
• Preventive and Corrective Maintenance
• Calibration

All of our documents are written to ensure compliance with your internal Quality Assurance personnel as well as cGMP and FDA requirements. We provide comprehensive IQ/OQ/PQ support for all phases of the FDA-approval process and revalidation services are available to assure continued compliance.

The quality of our validation services is further enhanced by a dedicated group of quality assurance professionals with a practical understanding of industry regulations to support you with a full range of technical expertise.

Read how our validation expertise has helped our customers.

To see a complete list of manufacturer's equipment that we service please click here.

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