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Attachment Replacement: Avoiding New Evidence Under an Old Decision

Use version history to establish which review and approval apply to a replacement attachment and preserve earlier decision scope.

Representative research photograph: Attachment Replacement: Avoiding New Evidence Under an Old Decision
Photo: U.S. Navy photo by Mass Communication Specialist 3rd Class Eduardo Zaragoza · License: Public domain · Cropped and resized.
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Updated

Replacing an attachment within a workflow does not automatically extend an earlier review or approval to the new content. An unchanged file name is not evidence that the supporting material remains the same version.

Preserve the meaning of data

Identify records, comments and decisions linked to the attachment. Distinguish decisions based on an earlier version from those based on the current one. Uploading a replacement does not establish that someone reviewed it. Explain how the system retains, removes and versions previous attachments within the approved record arrangements and who can retrieve them.

Worked example

For example, a certificate attached to a vendor assessment is renewed, while the review note still describes the earlier document’s scope. The team checks which claim the new attachment supports, assesses the effect of the change and adds any necessary re-review as an explicit step. A newer date does not establish suitability for every service.

Review checks

  • Trace a selected approval to the attachment version actually reviewed.
  • Test how different contents uploaded under one name are distinguished.
  • Link any required re-review decision to the attachment change.

Acceptance and boundaries

Acceptance means the content actually supporting a decision remains explainable later. Every replacement need not restart the entire workflow; a proportionate impact assessment may be appropriate. However, the scope of an earlier approval should not expand without rationale. Also check that exports and long-term retention preserve version relationships rather than retaining only the latest attachment.

Frequently asked questions

Does the same file name mean the same version?
No. File identity or version relationships should distinguish the actual content.
Does a replacement invalidate the previous approval?
It depends on impact. Explicitly decide the earlier approval scope and the assessment required for new content.

Sources

  1. FDA — Electronic systems, records and signatures in clinical investigations
  2. MHRA — Guidance on GxP data integrity