Validation

Validation is everything.

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 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

WE MANAGE the Lifecycle

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.

WE VALIDATE THESE EQUIPMENT & SYSTEMS

  • 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