Data Flow Mapping
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A documented diagram tracing how a specific piece of data moves — from creation, through every processing, transfer, and storage step, to its final reporting — across every system and manual step it passes through, used to identify where integrity risk, such as manual transcription or unreviewed exports, is introduced.
A data flow map answers a simple but often unasked question: after this result is generated, where does it actually go? It traces the path from the point of generation — an instrument, a manual entry, a sensor — through every system, interface, and person that touches it before it becomes part of a final report or batch record.
Mapping typically surfaces risks that are invisible when each system is validated in isolation: a manual transcription step between two validated systems, an unreviewed spreadsheet used to reformat data for a report, or an interface that was never itself qualified as part of either system’s validation.
Data flow mapping is a standard input to a data integrity risk assessment and to defining a computerized system’s true validated boundary — regulators increasingly expect to see the map, not just a description of the individual systems involved.
- —Traces a data point from creation through every system and manual step to its final report
- —Surfaces integrity risk hidden at the interfaces between validated systems
- —A standard input to data integrity risk assessment and validation scoping
- —Reveals manual transcription and unreviewed intermediate files that individual system validation misses
PIC/S PI 041-1; MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Data Flow Mapping?
A documented diagram tracing how a specific piece of data moves — from creation, through every processing, transfer, and storage step, to its final reporting — across every system and manual step it passes through, used to identify where integrity risk, such as manual transcription or unreviewed exports, is introduced.
Which regulations cover Data Flow Mapping?
PIC/S PI 041-1; MHRA GXP Data Integrity Guidance (2018)