Azure Imaging System Installation Qualification, Operational Qualification (IQ OQ) Package

The IQOQ package for the Azure Imaging Systems (AZI1100) is an essential tool for verification. The validation package contains the documentation required for regulatory compliance, SOPs, and laboratory management. It includes the protocols, checklists, targets, and certificates necessary to satisfy your validation requirements. These simple-to-follow instructions and durable checklist & logbook will assist you in performing the necessary tests, and maintaining accurate records.

Features

  • Detailed procedures for Installation Qualification (IQ) and Operational Qualification (OQ)
  • For use with any Azure Imaging System
  • Easy-to-use checklists with clear instructions

Package includes:

  • IQOQ procedure for 200-600,
  • Procedure,
  • Check-off sheet,
  • Test targets, and
  • Certification

Package does not include:

  • IQ OQ Service (AZI1102), sold separately

IQOQ phases for Azure Imaging Systems

1. Installation Qualification (IQ)

During IQ phase, the equipment is inspected to ensure it meets the requirements of Azure Biosystems and has been installed properly.

Includes:

  • Examining equipment design and supplied documentation
  • Assuring that the work area has the required space for the system to operate at peak performance
  • Determining installation parameters
  • Identifying required environmental controls and procedures
  • Installing the device
  • Verifying correct installment of the device
  • Establishing the procedures for monitoring, operating, and control of the device including responsible operators

2. Operational Qualification (OQ)

OQ phase tests the newly installed device to ensure it operates as expected and gauges the conditions under which it will continue to do so. Test runs will determine that the system is operating as expected. If OQ is successful, it will validate that the device is operating at optimal performance.

Includes:

  • Validating system internal diagnostics
  • Validating application operations

Ordering

Part NumberProduct Name
AZI1102Azure Imaging Systems IQ OQ ServiceREQUEST A QUOTE
AZI1100Azure Imaging Systems IQ OQ Validation PackageREQUEST A QUOTE

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