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Method Evaluation

CLSI MNav

Method Navigator

Developing or maintaining a laboratory-developed test can involve complex requirements, scattered guidance, and detailed documentation. CLSI Method Navigator brings key resources together to help teams understand what applies and move forward with more clarity.

With Method Navigator, users can:

  • View FDA, CLIA, New York State, and ISO requirements in one place. 
  • See how requirements connect to key phases in the test life cycle. 
  • Use downloadable templates to support evidence collection and documentation. 
  • Easily navigate to CLSI guidance documents that support compliance and quality management for all test life phases.


By making requirements and guidance easier to locate and apply, Method Navigator helps reduce time spent searching and supports a more organized approach to test development and maintenance.


Method Navigator is free to the public and also available as a subscription product. Users with eCLIPSE access can also benefit from enhanced functionality, including direct integration with the CLSI document library and workspace collaboration features.

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Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free
Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free