Metadata
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.
Metadata is the contextual data that gives a result its meaning — who acquired it, when, on what instrument, with which method and parameters, and any audit-trail entries and processing history. Without its metadata a value is just a number; the record is the result plus the metadata that makes it attributable and reconstructable.
For a chromatographic result, metadata includes the acquisition method, integration parameters, calibration references, sample sequence, timestamps, and the audit trail of any changes. The complete data set — result plus metadata — is the original record that must be preserved and reviewed.
A frequent data-integrity failure is retaining only the reported value while discarding or overwriting the metadata (e.g. keeping a final printout but not the audit trail of aborted or reprocessed runs), which breaks the ability to reconstruct what actually happened.
- —Contextual data that makes a result meaningful and attributable.
- —Includes method, parameters, timestamps, calibration, and audit trail.
- —Result + metadata together form the original record.
- —Discarding metadata is a common data-integrity failure.
MHRA GXP Data Integrity Guidance (2018), metadata definition; PIC/S PI 041-1 (2021).
Frequently asked questions
What is Metadata?
Metadata is the contextual data that gives a result its meaning — who acquired it, when, on what instrument, with which method and parameters, and any audit-trail entries and processing history. Without its metadata a value is just a number; the record is the result plus the metadata that makes it attributable and reconstructable.
Which regulations cover Metadata?
MHRA GXP Data Integrity Guidance (2018), metadata definition; PIC/S PI 041-1 (2021).