Assay Validation and Computer System Validation: Should Your Lab Use a Separate, Combined, or Hybrid Approach?
In regulated laboratory environments, validation is a crucial step for ensuring the reliability and integrity of scientific data. Two key types of validation often come into play: assay validation and computer system validation (CSV). Each type serves a distinct purpose. However, how they are applied varies across industries, based on the nature of the lab’s work, the particular regulatory standards that apply, and the lab’s risk tolerance.
