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Temperature Mapping is performed to determine if a storage area can maintain temperature within defined limits (Fridges,Freezers, Rooms, Warehouses and Incubators etc.). Sensors are distributed throughout the unit/room in pre-defined locations to confirm it performs within pre-defined set points.

The storage area is further challenged with additional tests such as empty mapping, loaded mapping, door open, powerfailure, pull down tests, fan failure etc. which are all performed to demonstrate the unit controls within pre-defined parameters and to determine the position of permanent monitoring/alarm probes.

Qualification and Validation Service Reports, Protocols and SOPs 

Our team of expert validation engineers have a focus on the quality and accuracy of all documentation provided to you for your project. Crest can be provided with report, protocoland SOP templates or we can draft documentation designed specifically for the project.

Qualification Protocol Test Case Examples

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ) or Continuous Qualification (CQ)

  • Power off / Power failure tests

  • Door Open tests

  • Temperature Distribution tests

  • Temperature Penetration tests

  • Alarm testing

  • Loaded and Empty Mappings

  • Instrument/equipment calibration

  • And several more…

Final Reports

We understand how critical it is that all documentation meets current Good Documentation Practices (cGDP). Our validation experts know what is expected and how to accurately generate reports. Crest’s validation report packages and summary reports are often leveraged during audits whether those are internal, customer.

We provide both hard and soft copies of the following as applicable

  • Final summary report

  • Temperature mapping data, humidity mapping data and more.

  • Executed protocol (IQ/OQ/PQ/CQ/RQ as requested)

  • Test equipment and materials: Calibration certificates, pre and post verification data

  • Sensor location information: Diagrams, drawings, images

  • Employee training records

  • Audit trails generated by our ValSuite validation and calibration software

  • Standard Operating Procedures (SOP's)

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