InfoQuest Consulting Group Inc. validates computerized systems unique to each client. An initial risk assessment based on government regulations such as 21 CFR 11, cGMP’s, and GxP’s, is necessary to determine what needs to be validated. User Requirement Specifications and Functional Specifications can then be analyzed and negotiated.

A validation master plan is created. Qualification protocols of Installation, Operation, and Performance (IQ/OQ/PQ) are executed, documented, and linked back to the original specifications. Standard Operating Procedures are created, filed for reference, and trained to operators of the system.

InfoQuest employs experienced validation consultants who are well versed on all federal regulations. Through careful planning, rigorous testing, and thorough documentation, our experienced validation consultants can validate and maintain validation of your computer system. System validation will certify the accuracy of the electronic records managed by the system and produce validation documentation tailored to satisfy auditors. Organizations not regulated by the FDA may also consider computer system validation in anticipation of liability issues.

InfoQuest Consulting Group Inc.’s Validation SOP’s:

• Develop User Requirement Specificaions
• Develop Design Specifications
• Develop Functional Requirements
• Develop Validation Master Plan
• Execute Validation Master Plan
• Installation Qualification Procedure (IQ)
• Operational Qualification Procedure (OQ)
• Performance Qualification Procedure (PQ)
• Document Validation Test Data