According to the most recent CLIA (Clinical Laboratory Improvement Amendments), any clinical laboratory that performs diagnostic, preventative, or treatment-based testing on human specimens must obtain CLIA certification and renew the applicable certificate(s) every two years.
Obtaining (and maintaining) CLIA certification requires clinical laboratories to effectively manage their documents and processes, CAPA, training assessment, customer complaints, and audit processes. Managing all of these requirements simultaneously can be extremely challenging with a paper-based or hybrid system.
MasterControl, a provider of GxP Process, quality audit and document control software provides solutions that can be launched from one Web-based platform and used to streamline and automate the tasks associated to achieve CLIA certification with the following :
The different types of CLIA certification that might be required of a company are listed below:
To learn more about the various types of CLIA certification, please refer to the government sponsored CLIA website.
Discover more on CLIA and how your company can establish a CLIA program that is effective and easy-to-manage, please feel free to contact a MasterControl representative.