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If these shorthand categories are not sufficient, use the document's Description attribute to give details.
Archival
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The Archival attribute is optional. Archival=Yes states that this file (or collection of files) is intended to meet the requirements of an electronic record as defined in 21 CFR 11. More specifically, the file (or set of files) must clearly establish a complete and non-redundant set of insertions, updates, and deletions of data values with full auditing and signature information (if available). |
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