Audit trails are considered the key to the security of a system since they track changes to data and metadata. In this way, an incomplete or absent audit trail can impact data integrity or even product quality. The absence of an audit trail is considered to be, “highly significant when there are data discrepancies” according to the FDA.

Externalization of R&D activities and the deluge of instrumental analytical data generated on a daily basis has resulted in increasing interest in analytical data standardization. Any standardization efforts, however, to either a single format or for data exchange between formats; should be weighed against the requirements of different users of that data, and hardware innovations.