Validation Deconstructed: Navigating IQ, OQ, CQ and PQ

Computer System Validation (CSV) is a process that organizations–particularly those in industries where there is potential risk to the public like product manufacturing and healthcare–go through to ensure products are safe, reliable, and effective as required by regulating bodies like the FDA and CAP/CLIA.

We are often asked by clients and prospects if our LIMS software, Labbit, is fully validated off-the-shelf. The answer is no, as it is actually not possible for a vendor of configurable software to provide a fully pre-validated system. The reason is that the software is a component of a unique system and validation requires investigation into how it operates within that system. Additionally, it is the responsibility of the system’s owner to validate it in the eyes of regulatory agencies. CSV requires more than software testing.