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A defensible archive preserves the record, its meaning, required metadata, history, readability, access control, and retrieval evidence for the approved period.
Define the record
Identify the record types, source system, metadata, attachments, relationships, audit trail, signatures, and revision history that must be retained. Document the retention rule and the owner.
A PDF export may preserve appearance while losing structured data, history, or signature context. Decide whether the export is the record, a copy, or an index to the controlled source.
Control retention rules
Retention should be based on applicable requirements, company procedures, contracts, and process decisions. Define legal holds, extensions, disposition approval, and protection from unauthorised deletion.
Do not use one period for every record simply because the archive tool has one default. Different records may have different obligations.
Preserve meaning and attribution
Retain timestamps, user identity, status, revision, signature manifestation, units, and relationships when they are needed to understand the record. Document any transformation and verify it during archival testing.
Data integrity principles such as attributable, legible, contemporaneous, original or true copy, and accurate should inform the design. They are properties to evidence, not labels to paste into a policy.
Test retrieval
A restore or retrieval test should show that an authorised reviewer can locate, open, interpret, and verify the record. Test older formats, attachments, search fields, access restrictions, and audit history where relevant.
Include the archive in periodic review and change assessment. A vendor migration or format change can affect readability even when the record count is unchanged.
Dispose under control
When the retention period ends, verify that no hold or investigation prevents disposition. Approve the action, record what was disposed, when, by whom, and how the system prevented unauthorised deletion.
| Archive property | Question |
|---|---|
| Completeness | Are required records, metadata, history, and links present? |
| Integrity | Can the reader tell who did what and when? |
| Readability | Can authorised users open and interpret the record? |
| Retrievability | Can the record be found within the required process? |
| Disposition | Is deletion approved and documented? |
FAQ
Is a backup the same as an archive?
No. A backup supports recovery of a system. An archive supports controlled retention and retrieval of records.
Can records be converted to another format?
Yes, when the conversion is controlled, assessed, documented, and verified to preserve required meaning and evidence.
Who approves disposition?
The applicable records and quality procedures should name the accountable owner and required review.
How do you prove an archive is readable?
Perform controlled retrieval tests using representative records and document the result and any exceptions.
Decision rule: choose evidence from the consequence of failure, the control being relied on, and the ability to detect a problem. A larger document set is not automatically stronger. Clear scope, reproducible evidence, and an approved conclusion are what make the decision defensible.
Keep the rationale with the controlled record. Future reviewers should be able to see what was considered, what was tested or reviewed, what remains uncertain, and who accepted the residual risk.
During review, compare the approved requirement with observed use, current configuration, and retained evidence. That simple comparison often finds drift before an auditor does.
For related work, read our validation traceability matrix guide.
Primary sources
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