Abstract: A method for automatically tracking compliance in a clinical trials process involving one or more operations comprising selecting a container; associating an identifier with the container, the identifier having a unique signature data item thereon; reading the unique signature data item to a relational database; performing a first operation relating to the container; checking the performance of the first operation against a compliance standard; following the successful completion of the first operation, writing an associated compliance data item to the relational database; optionally performing one or more further operations relating to the container; and following the successful completion of each optional further operation or a package thereof, writing an associated compliance data item to the database.