ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Trustworthy Record

For a record to remain reliable, authentic, with its integrity maintained, and useable for as long as the record is needed, it is necessary to preserve its content, context, meaning, and sometimes its structure.

A trustworthy record preserves the actual content of the record itself and information about the record that relates to the context in which it was created and used. Specific contextual information will vary depending upon the business, legal, and regulatory requirements of the business activity. The record’s reliability and authenticity may be impaired if its structure or arrangements are not preserved. The acronym ALCOA is used to summarize the key properties of a trustworthy record.

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

Publication Date: 2007

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