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In Vitro Diagnostics (IVD)


Because of the high level of regulation, IVD applications require special attention to process control and data integrity.

IVD applications require that the automated system be able to identify the operator. The system should allow for validation of the bioanalytical method as well as the correct data handling. A high level of process control is required to detect or prevent user errors, detect system errors and respond appropriately by flagging results as invalid. Traceability of every step is a must in order to determine if the protocol was followed.