Quality Services Experience

Polaris Automation offers a full range of validation and commissioning services to clients in regulated industries.  We have knowledge in all areas of a typical manufacturing plant; from the facilities, utilities, process equipment, and packaging equipment, to the manufacturing network.  We have expertise in food, pharmaceutical, biotech, and medical device environments.  Collectively, Polaris Automation, Inc. offers a wealth of validation experience that we offer to support our clients in regulated facilities around the world.  Our team will partner with your quality and engineering personnel to provide quality and validation deliverables according to your requirements. We will act on your behalf from project inception to completion, in both a project management role and a project delivery role.  We are committed to providing superior consulting services in an environment that demands adherence to exacting regulatory standards, set budget parameters, and tight delivery schedules.

The Polaris Automation Quality Services team has worked with clients on everything from basic manual systems to complex automated systems. This includes all areas of facilities and manufacturing processes including utilities, HVAC systems, packaging and labeling equipment, vision systems, process equipment such as fillers, homogenizers, tanks, spray dryers, purified water systems, CIP systems and much more.

 

Lifecycle Documentation:

  • Master Planning
  • Risk Assessments
  • Requirements Traceability Matrix
  • User Requirements Specifications
  • Functional Requirements Specification
  • Software Design Specification
  • Design Review/Acceptance

Integrated Commissioning:

  • Utilities/Facilities/Equipment
  • Commissioning Plans
  • Engineering Turnover Package (ETOP)
  • Code Review
  • Receipt and Installation Verification
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Functional Testing
  • Integration Testing
  • Commissioning Summary

Qualification Documentation and Execution:

  • Qualification/Test Plans
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Incident Reporting/Resolution
  • Qualification Summary Reports

Additional Validation Services:

  • System Validation Audits
  • Remediation/Retrospective
  • Vendor Audits — software and equipment
  • Internal Compliance Audits (Quality, Safety, Environmental)
  • Change Controls
  • SOPs
  • Operating Instructions
  • User Manuals
  • Quality System Development
  • Hazards Analysis and Critical Control Point (HACCP) Assessment