Validation and Qualification Services

Our Validation and Qualification Services follow the Food and Drug Administration’s (FDA) General Principals of Process Validation and work to provide clients with documentation that confirms the validated or qualified status of their equipment, facility, or process. This documented testing is performed under highly controlled conditions and demonstrates that processes, methods, and systems consistently produce results meeting pre-determined acceptance criteria. The resulting Validation Master Plans and Protocols are appropriately defined in accordance with FDA, USP, ISPE, and other relevant guidelines.

Sensitech’s broad global footprint ensures that validation or qualification services take into account the guidelines or expectations of the regulatory agencies for not only the local country, but also for associated shipping locations. Protocols are executed following Good Documentation Practices and the resulting summary reports are tailored for the specific equipment, facility, or process being validated or qualified.

Benefits of Service

• Assists in complying with global regulatory expectations and standards-based guidance

• Provides study protocols based on industry best practices

• Supports internal and external audit procedures

• Includes review and evaluation of equipment or facility data including: manuals, mechanical drawings, Piping and Instrumentation Diagrams (P&IDs), calibration information, etc.

• Incorporates Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Services Offered

• Process Validation

• HVAC System Validation

• Autoclave Validation

• Refrigerator and Freezer Validation

• Incubator Validation

• Walk-in Cold Room Validation

• Transportation Qualification

• Trailer Qualification

• Sea and Air Container Qualification

• Package Performance Qualification