Validation

Equipment Life Cycle and Validation Services

Decontamination and Sterilization Experts that Understand FDA Requirements
STERIS and our preferred team of validation consultants will work with your company to facilitate equipment design and planning. Validation Master Planning can be performed using GAMP5 or other validation models.

Our Team Offers:

• Validation Master Plan (VMP) development
  
• User Requirement Specification (URS) consulting
• Functional Design Specification (FDS) review

Superior Qualification Protocols and Documentation Services
Our documentation starts in the factory and supports each piece of equipment throughout its life cycle. No other method of documentation is more accurate or efficient. STERIS and our preferred team of validation consultants will work to understand your process-specific documentation needs to provide protocols that complement your existing documentation formats.

Our Team Offers:

• Design Qualification (DQ) documentation development and execution
• Factory Acceptance Test (FAT) documentation development and execution
• Site Acceptance Test (SAT) documentation development and execution
• Standard Operating Procedure (SOP) development
• Installation Qualification (IQ) documentation development and execution
• Operational Qualification (OQ) documentation development and execution
• Performance Qualification(PQ) documentation development and execution

Seamless Life Cycle Management through Turnkey Solutions

• Equipment start-up/commissioning
• Installation services
• NIST Calibration
• Reinstallation service
• Revalidation services
• Cycle development
• Validation
• Maintenance services and/or training

Equipment:

• Steam Sterilizers
• Ethylene Oxide Sterilizers
• VHP Sterilization/Biodecontamination Systems
• Washers
• Pure Steam Generators
• Water Stills
• Control System Upgrades

Contact: Validation@steris.com 800.333.8828