ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Electronic records that include processing parameters and audit trail logs. Metadata allows reviewers to replay the original result, or reconstruct a final report from raw data. In chromatography, metadata include integration parameters and calibration tables. An example of metadata can be in long division “1,000 ÷ 5” would be the raw data, the work you had to show on your paper in fourth grade math class would be the metadata, and “200” would be your result.


Data used to describe other data. It can be used to describe information such as file type, format, author, user rights, etc. and is usually attached to files, but invisible to the user.

Publication Source: GAMP® Good Practice Guide: Global Information Systems Control and Compliance

Publication Date: 2005


ISO-15489 defines metadata as: Data describing context, content and structure of records, and their management through time.

Metadata also can be described as data associated with records required to enhance/interpret or support the record of interest to facilitate its retrieval. Or simplified: Data about data. Digital metadata normally occurs in sets of attributes that are standardized for a particular purpose so they can be searched, aggregated, etc.

Metadata is necessary to ensure a meaningful presentation or interpretation of the electronic record, or for the reconstruction of the electronic record.

Metadata comes in many forms, including the label on a disk or tape, filename, date/time stamp, sample ID and data structure/relationship. Another example of metadata is a data dictionary file which documents a relational database structure, attributes, relations, key fields, format protection, ownership, etc.

Publication Source: GAMP® Good Practice Guide: Electronic Data Archiving

Publication Date: 2007

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