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 a CLIA certificate and renew the CLIA waiver every two years.
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To determine whether a laboratory's tests are eligible for a waiver certificate, laboratory representatives may visit the FDA's online waived test listing. This listing provides information useful to any clinical laboratory that conducts clinical tests eligible for a CLIA waiver certificate.
Once a clinical test has met the requirements for a CLIA waiver, it can be marketed without the delays commonly associated with obtaining CLIA certificates.
Although your company may qualify for a CLIA waiver, a waiver may not be necessary with integrated software solutions. The reason is because integrated software solutions make it possible to quickly obtain CLIA certificates.
When searching for CLIA compliant solutions, clinical laboratory professionals should take into consideration that fact that the CLIA-related requirements that must be met.
Document control, change control, customer complaints management, training and CAPA control requirements are all stipulated by CLIA regulations. MasterControl provides solutions for those needing CLIA waivers by streamlining all of these processes and can configure and launch them from one Web-based platform making CLIA compliance and quality related processes easy to manage in only a fraction of the time that was previously required.
MasterControl, a provider of GxP process solutions that help achieve CLIA waivers, has quality audit and document control software solutions that can be launched from one web-based platform and used to streamline and automate the tasks associated with the following:
To learn more about a CLIA waiver, and about automated CLIA compliance, please feel free to contact a MasterControl representative.