Validation Services

We use a standardized approach for validation and documentation to save you time and money.

When it comes to validation services, you need an industry expert you can trust.

Connect with a POA engineer

POA has been a leader in validation for more than fifteen years. Our experts provide professional validation services for the pharmaceutical, biotech, and medical device industry, plus many more applications. Our mission is to ensure that your operation is in compliance with the FDA, GMP, ISO9001, and ISO13485 every single time.

Regardless of what process best fits your organization, POA can get you the qualification you need according to your requirements. We’ve developed a standardized approach to validation and documentation which reduces project execution timelines, validation efforts, and rework cost. Use our validation services to prepare and execute documents for:

Installation Qualification
Operational Qualification
Design Qualification
Performance
Qualification
Factory and Site
Acceptance Testing
POA can provide User Requirements, Risk Assessments, and Validation Master Plans

We understand that each project requires specialized equipment unique to its specific field. This is why POA customizes each regulatory test to address every necessity.

WE PROVIDE DOCUMENTATION

POA authors or can assist with authoring all the documents needed for regulatory compliance.

Validation Master Plan
SOPs
Risk Assessment FMEA
User Requirement Specification
Functional Specification
Design Qualification
Factory Acceptance Test
Site Acceptance Test
Installation Qualification / Operational Qualification / Performance Qualification
Summary Report
Scheduled and Unscheduled Re-Validation

POA manages the entire lifecycle for controlled temperature environments (CTEs) and other equipment.

We work with you from selection, onboarding, validation, periodic re-validation, and decommissioning.

Validatable Environmental Monitoring Systems
Validatable Cold Room Controls
Validatable Freezer Controls
Validatable Tray Dryer Controls
Calibration Services
Startup, Commissioning, and Qualification
Temperature Mapping PQ
Validation Summary Reports

In addition, we provide temperature mapping and validation for a variety of applications, including:

Stability Chamber Mapping
Incubators
Warehouse Temperature Mapping
Cold Room Temperature Mapping
Freezers
Ultra-Low Freezers

…Plus many more.

Continuous Monitoring Systems (CMS)
Bio-Safety Cabinets and Hoods
Powder and Fume Hoods
Refrigerators
Freezers
Warehouses
Chart Recorders
Temperature controllers
Building Automation Systems (BAS)
Autoclaves
Balances/Scales
Centrifuges
Incubators
CO2 Incubators
Incubator shakers
Ovens
Hot Boxes
Heat Sealers
Lyophilizers/Freeze Dryers
Temperature Monitoring Systems

Validation is everything.

When it comes to validation services, you need an industry expert you can trust.

WE PROVIDE DOCUMENTATION

WE MANAGE the Lifecycle

WE VALIDATE THESE EQUIPMENT & SYSTEMS

OREGON

CALIFORNIA