CLSI EP19-Ed3

EP19 is organized around the Test Life Phases Model, which is the concept that all test methods undergo establishment by a developer, followed by implementation by the end user, all sequentially. For the purposes of EP19, the term “test method” includes the processes, reagents, supplies, calibrators, control material, hardware, software, and any other components that make up a test. EP19 describes the considerations and processes for planning, performing, and documenting test method evaluations by referring users to the appropriate CLSI EP documents, along with other related documents and resources when applicable. Effective use of EP19 is based on the premise that both the developer and the end user have a QMS in place with appropriate controls over all essential processes, including personnel, environment, general processes, and documentation. Users should refer to CLSI electronic product Method Navigator1 in conjunction with EP19.

Because CLSI documents are regularly updated, the EP documents can be considered generally accepted good practice for how test methods should be evaluated. EP19 provides general reference on the specific CLSI documents that are useful for test method evaluations and provides considerations for how users could most effectively benefit from this information. EP19 users should refer to the referenced CLSI documents for sufficient details to plan, perform, and interpret the evaluations correctly.