Validation

Processes

There are many interpretations of process validation, but industry experts agree that it should the final step in the product and/or process development cycle that ensures production is accurate and consistent over time.

In fact, a failed process validation is often the result of incomplete or inadequate process development and testing. The engineering and science professionals at QSP understand the confluence of equipment, materials, facilities, computer systems and people that make up a successful process. Through careful design and detailed analysis, QSP can help your organization validate the processes critical to your operation to ensure each operates within specifications and complies with FDA expectations.

QSP is adept at developing and executing validation studies that demonstrate process performance and consistency. Our science and engineering experts are knowledgeable in many areas including process analytical technology (PAT), enterprise data management and new software platforms that can be employed to meet your specific goals.

Our team is experienced in developing and executing:

• Validation Master Plans (VMP)
• Process Demonstration and Testing User Requirements Specifications (URS)
• Functional Requirements Specifications (FRS)
• Failure Modes and Effects Analysis (FMEA)
• Risk Assessments (RA)
• Validation study protocols and test plans